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Does anyone not know what implanted breasts look like? Just look at photos in People magazine. And recent straw poll points out POV of droliver version.
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A '''breast implant''' is a [[prosthesis]] used to enlarge the size of a woman's [[breast]]s (known as '''breast augmentation''') for [[cosmetic surgery|cosmetic reasons]], to [[breast reconstruction|reconstruct the breast]] (e.g. after a [[mastectomy]] or to correct genetic deformities), or as an aspect of [[sex reassignment surgery male-to-female|male-to-female sex reassignment surgery]].
[[Image:Before after.jpg|thumb|Patient with breast implants]]

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A '''breast implant''' is a [[prosthesis]] used to enlarge the size of a woman's [[breast]]s (known as '''breast augmentation''' or '''breast enlargement''') for [[cosmetic surgery|cosmetic reasons]], to [[breast reconstruction|reconstruct the breast]] (e.g. after a [[mastectomy]] or to correct genetic deformities), or as an aspect of [[sex reassignment surgery male-to-female|male-to-female sex reassignment surgery]].
According to the [[American Society of Plastic Surgeons]], breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In [[2005]], 291,000 breast augmentation procedures were performed.<ref>[http://www.plasticsurgery.org/news_room/press_releases/2005-procedural-stats.cfm 10.2 Million Cosmetic Plastic Surgery Procedures in 2005]. American Society of Plastic Surgeons. 15 March 2006. Retrieved 17 April 2006.</ref>
According to the [[American Society of Plastic Surgeons]], breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In [[2005]], 291,000 breast augmentation procedures were performed.<ref>[http://www.plasticsurgery.org/news_room/press_releases/2005-procedural-stats.cfm 10.2 Million Cosmetic Plastic Surgery Procedures in 2005]. American Society of Plastic Surgeons. 15 March 2006. Retrieved 17 April 2006.</ref>


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== Patient characteristics ==
== Patient characteristics ==


Patients seeking breast augmentation are usually younger, healthier, from higher socio-economic status, and more often married with children than the population at large.<ref name="Brinton2000">{{cite journal | author = Brinton L, Brown S, Colton T, Burich M, Lubin J | title = Characteristics of a population of women with breast implants compared with women seeking other types of plastic surgery. | journal = Plast Reconstr Surg | volume = 105 | issue = 3 | pages = 919-27; discussion 928-9 | year = 2000 | id = PMID 10724251}}</ref> . Many of these patients have greater distress about their appearance in a variety of situations, and have endured more frequent teasing about their appearance. Studies have identified a pattern (shared by many cosmetic surgery procedures) that suggest women who undergo breast implantation are slightly more likely to have undergone psychotherapy, have low levels of self-esteem, and have higher prevalences of [[depression]], [[suicide]] attempts, and mental illness (including [[body dysmorphia]]) as compared to the general population.<ref name="Sarwer2003">{{cite journal | author=Sarwer DB,, ''et al.'' | title=Body image concerns of breast augmentation patients. | journal=Plast Reconstr Surg.| year=2003 | issue=July| pages=83-90| id=PMID 12832880 }}</ref> </p>
Patients seeking breast augmentation are usually younger, healthier, and from higher socio-economic status than the population at large.<ref name="Brinton2000">{{cite journal | author = Brinton L, Brown S, Colton T, Burich M, Lubin J | title = Characteristics of a population of women with breast implants compared with women seeking other types of plastic surgery. | journal = Plast Reconstr Surg | volume = 105 | issue = 3 | pages = 919-27; discussion 928-9 | year = 2000 | id = PMID 10724251}}</ref> Many of these patients have greater distress about their appearance, and have been diagnosed with body dysmorphic disorder, a condition defined as “a preoccupation with an imagined or slight defect in appearance that leads to significant impairment in functioning.” <ref name="Sarwer2003">{{cite journal | author=Sarwer DB,, ''et al.'' | title=Body image concerns of breast augmentation patients. | journal=Plast Reconstr Surg.| year=2003 | issue=July| pages=83-90| id=PMID 12832880 }}</ref> This psychiatric problem has been found to be unresponsive to plastic surgery and effectively treated by psychotherapy. <ref name="Crerand 2006">{{cite journal | author=Crerand CE,, ''et al.'' | title=Body dysmorphic disorder and cosmetic surgery. | journal=Plast Reconstr Surg.| year=2006 | issue=July| pages=1672-1802|id= PMID 17102719 }}</ref> <p>


Post-operative surveys on mental health and quality of life issues have shown short term improvement on a number of dimensions including: physical health, physical appearance, social life and self confidence.<ref name="Young1994">{{cite journal | author=Young VL, ''et al.'' | title=The efficacy of breast augmentation: breast size increase, patient satisfaction, and psychological effects. | journal=Plast Reconstr Surg.| year=1994 | issue=Dec| pages=958-69| id=PMID 7972484
Post-operative surveys on mental health and quality of life issues have shown short-term improvement in confidence regarding the appearance of the breasts, but after six months there was no improvement in self-esteem or general self-confidence. <ref name="Sarwer2002">{{cite journal | author=Sarwer DB,, ''et al.'' | title= An Investigation of Changes in Body Image following Cosmetic Surgery. | journal=Plast Reconstr Surg.|year=2002 | issue=January| pages=363-369|}}</ref>
When the two major implant manufacturers objectively compared self-esteem, quality of life, and self-concepts just before augmentation and 3-4 years afterwards, they found no improvement in self-concept, confidence, mental health, or quality of life on most measures; the one improvement was in feeling more sexually attractive <ref name="Inamed2006">{{cite journal | title=
}}</ref><ref name="chahraoui2006">{{cite journal | author=Chahraoui K,, ''et al.'' | title=Aesthetic surgery and quality of life before and four months postoperatively | journal=J Long-Term Effects Medical Implants | year=2006 | pages=207-210 | id=PMID 16181718 }}</ref><ref name="Cash2002">{{cite journal | author=Cash TF, ''et al.'' | title=Women's psychosocial outcomes of breast augmentation with silicone gel-filled implants: a 2-year prospective study. | journal=Plast Reconstr Surg.| year=2002 | issue=May| pages=2112-21| id=PMID 11994621 }}</ref>
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Important Information for Women About Breast Augmentation with Inamed Silicone Gel-Filled Implants.| year=2006 | http://www.fda.gov/cdrh/pdf2/P020056d.pdf }}</ref>
Longer term follow suggests these improvements may be transitory, with the exception of body esteem related to sexual attractiveness. <ref name="Inamed2006">{{cite journal | title=
<ref name="Mentor2006">{{cite journal | title=
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Important Information for Women About Breast Augmentation with Inamed Silicone Gel-Filled Implants.| year=2006 | http://www.fda.gov/cdrh/pdf2/P020056d.pdf }}</ref>
Important Information for Women About Breast Augmentation with Mentor MemoryGel Silicone Gel-Filled Implants.| year=2006 | http://www.fda.gov/cdrh/pdf3/P030053d.pdf }}</ref>
The large majority of patients reports being satisfied long-term with their implants even when they have required reoperation for complications or aesthetic reasons.<ref name="HandelN">{{cite journal | author=HandelN, ''et al.'' | title=A long-term study of outcomes, complications, and patient satisfaction with breast implants. | journal=Plast Reconstr Surg.| year=2006 | issue=Mar| pages=757-67| id=PMID 16525261 }}</ref> <ref name="Young1994">{{cite journal | author=Young VL, ''et al.'' | title=The efficacy of breast augmentation: breast size increase, patient satisfaction, and psychological effects. | journal=Plast Reconstr Surg.| year=1994 | issue=Dec| pages=958-69| id=PMID 7972484
However, other studies have found that most patients report being satisfied with their implants even when they have required reoperation for complications or aesthetic reasons.<ref name="HandelN">{{cite journal | author=HandelN, ''et al.'' | title=A long-term study of outcomes, complications, and patient satisfaction with breast implants. | journal=Plast Reconstr Surg.| year=2006 | issue=Mar| pages=757-67| id=PMID 16525261 }}</ref> </p>
}}</ref> </p>


== Procedure ==
== Types of implants ==
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=== Saline implants ===
The surgical procedure for breast augmentation takes approximately one to two hours.<ref>[http://www.aiplasticsurgery.com/procedures_breastaugmentation.php Breast Augmentation]. Advanced Institute for Plastic Surgery. Retrieved 22 February 2007.</ref> Variations in the procedure depends on the incision type, implant material, and implant pocket placement.
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Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion<ref name="Arion1965">{{cite journal | author=Arion HG| title=Retromammary prosthesis| journal=C R Soc Fr Gynecol | year=1965| volume=5}}</ref> with the goal of being surgically placed via smaller incisions. These original devices had a high failure rate and were discontinued in the early 1970s {{Fact|date=February 2007}}. The current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have high failure rates in vivo.<!-- --><ref name="Stevens">{{cite journal | author=Stevens WG, Hirsch EM, Stoker DA, Cohen R.| title=In vitro deflation of prefilled saline breast implants.| journal=Plast Reconstr Surg.| year=2006 | pages=347-9| volume=118 | issue=2 | id=PMID 16874200}}</ref>

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=== Incision types ===

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Breast implants for augmentation may be placed via various types of incisions:
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* '''Inframammary''' - an incision is placed below the breast in the infra-mammary fold (IMF). This incision is the most common approach and affords maximum access for dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required.
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* '''Periareolar''' - an incision is placed along the areolar border. This incision provides an optimal approach when adjustments to the IMF position or mastopexy (breast lift) procedures are planned. The incision is generally placed around the inferior half, or the medial half of the areola's circumference. Larger silicone gel implants are difficult to place via this incision.
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* '''Transaxillary''' - an incision is placed in the armpit and the dissection tunnels medially. This approach allows implants to be placed with no visible scars on the breast. Transaxillary procedures can be performed with or without an endoscope (tiny lighted camera).
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* '''Transumbilical (TUBA)''' - a less common technique where an incision is placed in the navel and dissection tunnels superiorly. This approach enables implants to be placed with no visible scars on the breast, but makes appropriate dissection and implant placement more difficult. Transumbilical procedures may be performed bluntly or with an endoscope (tiny lighted camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell during blunt insertion.
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* '''Transabdominoplasty (TABA)''' - procedure similar to TUBA, where the implants are tunneled up from the abdomen into bluntly dissected pockets while a patient is simultaneously undergoing an abdominoplasty procedure.

=== Types of implants ===
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==== Saline implants ====
[[Image:Silicone gel-filled breast implants.jpeg|thumb|Saline-filled breast implants]]
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Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion<ref name="Arion1965">{{cite journal | author=Arion HG| title=Retromammary prosthesis| journal=C R Soc Fr Gynecol | year=1965| volume=5}}</ref> with the goal of being surgically placed via smaller incisions. Current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have high failure rates in vivo.<!-- --><ref name="Stevens">{{cite journal | author=Stevens WG, Hirsch EM, Stoker DA, Cohen R.| title=In vitro deflation of prefilled saline breast implants.| journal=Plast Reconstr Surg.| year=2006 | pages=347-9| volume=118 | issue=2 | id=PMID 16874200}}</ref>


Saline-filled implants are the most common implant used in the United States due to restrictions on silicone implants, but are rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, plastic surgeons believe that silicone gel implants are the superior device. In patients with more breast tissue, however, saline implants can look very similar to silicone gel.<p>
Saline-filled implants are the most common implant used in the United States due to restrictions on silicone implants, but are rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, plastic surgeons believe that silicone gel implants are the superior device. In patients with more breast tissue, however, saline implants can look very similar to silicone gel.<p>


==== Silicone gel implants ====
=== Silicone gel implants ===


[[Thomas Cronin (surgeon)|Thomas Cronin]] and [[Frank Gerow]], two [[Houston, Texas|Houston]], [[Texas]], [[plastic surgery|plastic surgeons]], developed the first silicone breast prosthesis with the [[Dow Corning Corporation]] in [[1961]]. The first woman was implanted in [[1962]]. Silicone implants are generally described in terms of five generations which segregates common characteristics of manufacturing techniques.
[[Thomas Cronin (surgeon)|Thomas Cronin]] and [[Frank Gerow]], two [[Houston, Texas|Houston]], [[Texas]], [[plastic surgery|plastic surgeons]], developed the first silicone breast prosthesis with the [[Dow Corning Corporation]] in [[1961]]. The first woman was implanted in [[1962]]. Silicone implants are generally described in terms of five generations which segregates common characteristics of manufacturing techniques.
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Evaluation of "[[gummy bear]]" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been used longer in other countries. Plastic surgeons believe that the greater gel cohesion in these implants is likely to significantly reduce the possibility of silicone migration. Early reports of these devices have shown significant improvements in safety and efficacy, over the older implants. <!-- --><ref name="Brown2005">{{cite journal | author=Brown MH, Shenker R, Silver SA | title=Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery | journal=Plast Reconstr Surg | year=2005 | pages=768-79; discussion 780-1 | volume=116 | issue=3 | id=PMID 16141814}}</ref><!-- --><ref name="Fruhstorfer2004">{{cite journal | author=Fruhstorfer BH, Hodgson EL, Malata CM | title=Early experience with an anatomical soft cohesive silicone gel prosthesis in cosmetic and reconstructive breast implant surgery | journal=Ann Plast Surg | year=2004 | pages=536-42 | volume=53 | issue=6 | id=PMID 15602249}}</ref><!-- --><ref name="Heden2001">{{cite journal | author=Heden P, Jernbeck J, Hober M | title=Breast augmentation with anatomical cohesive gel implants: the world's largest current experience | journal=Clin Plast Surg | year=2001 | pages=531-52 | volume=28 | issue=3 | id=PMID 11471959}}</ref>
Evaluation of "[[gummy bear]]" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been used longer in other countries. Plastic surgeons believe that the greater gel cohesion in these implants is likely to significantly reduce the possibility of silicone migration. Early reports of these devices have shown significant improvements in safety and efficacy, over the older implants. <!-- --><ref name="Brown2005">{{cite journal | author=Brown MH, Shenker R, Silver SA | title=Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery | journal=Plast Reconstr Surg | year=2005 | pages=768-79; discussion 780-1 | volume=116 | issue=3 | id=PMID 16141814}}</ref><!-- --><ref name="Fruhstorfer2004">{{cite journal | author=Fruhstorfer BH, Hodgson EL, Malata CM | title=Early experience with an anatomical soft cohesive silicone gel prosthesis in cosmetic and reconstructive breast implant surgery | journal=Ann Plast Surg | year=2004 | pages=536-42 | volume=53 | issue=6 | id=PMID 15602249}}</ref><!-- --><ref name="Heden2001">{{cite journal | author=Heden P, Jernbeck J, Hober M | title=Breast augmentation with anatomical cohesive gel implants: the world's largest current experience | journal=Clin Plast Surg | year=2001 | pages=531-52 | volume=28 | issue=3 | id=PMID 11471959}}</ref>


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== Systemic illness and disease==
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=== Implant pocket placement ===
[[Image:BreastImplant(inamed35).jpg|thumb|250px|Subglandular breast implant diagram]]
[[Image:BreastImplant(inamed36).jpg|thumb|250px|Submuscular breast implant diagram]]
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The placement of implants is described in relation to the pectoralis major muscle.
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* '''Subglandular'''- implant between the breast tissue and the pectoralis muscle. This position closely resembles the plane of normal breast tissue and is felt by many to achieve the most aesthetic results. The subglandular position in patients with thin soft-tissue coverage is most likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates are also slightly higher with this approach
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* '''Subfascial'''- the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated, but proponents believe the thin vascularized fascia may help with coverage and sustaining positioning of the implant.
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* '''Subpectoral''' ("dual plane") - the implant is placed underneath the pectoralis major muscle after releasing the inferior muscular attachments. As a result, the implant is partially beneath the pectoralis in the upper pole, while the lower half of the implant is in the subglandular plane. This is the most common technique in North America and achieves maximal upper implant coverage while allowing expansion of the lower pole. Capsular contracture rates have been lower after widespread adoption of this technique.
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* '''Submuscular'''- the implant is placed below the pectoralis without release of the inferior origin of the muscle. Total muscular coverage may be achieved by releasing the lateral chest wall muscles (seratus and/or pectoralis minor) and sewn to the pectoralis major. This technique is most commonly used for maximal coverage of implants used in breast reconstruction.


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Since the early 1990s, a number of independent systemic (comprehensive) reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no conclusive evidence of a causal link between the implantation of silicone breast implants and systemic disease.[http://laurent.benadiba.free.fr/SITE%20These/Analyse%20resultats.htm][http://www.tga.gov.au/docs/pdf/breasti4.pdf][http://www.secpre.org/pdf/equam.pdf][http://www.silicone-review.gov.uk/press_notice.htm][http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-breast-mammaire/eapbi_rop_gceim_crd_2005-09-29_e.html] <p>
== Recovery ==
Depending on the level of activity required, patients are generally able to return to work or school in approximately one week time. Scars from the breast augmentation surgery will last six weeks or longer. The scars begin to fade several months after surgery.<ref>[http://www.aiplasticsurgery.com/procedures_breastaugmentation.php Breast Augmentation]. Advanced Institute for Plastic Surgery. Retrieved 22 February 2007.</ref>


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Thousands of women still claim that they have become ill from their implants. Complaints include [[neurology|neurological]] and [[rheumatology|rheumatological]] problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. <ref name=Vasey2003>{{cite journal | author=Vasey FB, Zarabadi SA, Seleznick M, Ricca L | title=Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined | journal=J Rheumatol | year=2003 | pages=2092-4 | volume=30 | issue=10 | id=PMID 14528500}}</ref> More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.<p>
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== Systemic illness and disease==


As studies have followed women with implants for a longer period of time, more data are available on systemic diseases as well as autoimmune symptoms. A 2004 Danish study reported that women who had breast implants for an average of 19 years were no more likely to be diagnosed with classic autoimmune diseases than breast reduction patients, but were "significantly more likely" to report "fatigue", "Raynaud-like symptoms (white fingers and toes when exposed to cold)", and "memory loss" and other "cognitive symptoms", compared to women of the same age in the general population. <ref name="Breiting2004">{{cite journal | author=Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S | title=Long-term health status of Danish women with silicone breast implants | journal= Plastic and Reconstructive Surgery| year=2004 | pages=217-226 | volume=114 | id= PMID 15220596}}</ref> <p>
⚫
Since the early 1990s, a number of independent systemic (comprehensive) reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no clear evidence of a causal link between the implantation of silicone breast implants and systemic disease.[http://laurent.benadiba.free.fr/SITE%20These/Analyse%20resultats.htm][http://www.tga.gov.au/docs/pdf/breasti4.pdf][http://www.secpre.org/pdf/equam.pdf][http://www.silicone-review.gov.uk/press_notice.htm][http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-breast-mammaire/eapbi_rop_gceim_crd_2005-09-29_e.html] <p>


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Thousands of women still claim that they have become ill from their implants. Complaints include [[neurology|neurological]] and [[rheumatology|rheumatological]] problems. Some studies have suggested that subjective and objective symptoms of women with implants may improve when their implants are removed. <ref name=Vasey2003>{{cite journal | author=Vasey FB, Zarabadi SA, Seleznick M, Ricca L | title=Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined | journal=J Rheumatol | year=2003 | pages=2092-4 | volume=30 | issue=10 | id=PMID 14528500}}</ref> <p>


As studies have followed women with implants for a longer period of time, more data has become available on systemic diseases as well as autoimmune symptoms. Several large studies from the national health registry in Denmark found implant recipients no more likely to be diagnosed with an increased incidence of classic auto-immune symptoms as compared to women of the same age in the general population,<ref name="Breiting2004">{{cite journal | author=Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S | title=Long-term health status of Danish women with silicone breast implants | journal= Plastic and Reconstructive Surgery| year=2004 | pages=217-226 | volume=114 | id= PMID 15220596}}</ref> and that musculoskeletal symptoms were generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.<ref name="Kjoller2004">{{cite journal | author=Kjoller K, Holmich LR, Fryzek JP, Jacobsen PH, Friis S, McLaughlin JK, Lipworth L, Henriksen TF, Hoier-Madsen M, Wiik A, Olsen JH| title=Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implants.| journal= Plastic Ann Plast Surg. | year=2004 | pages=1-7| volume=52 | id= PMID 14676691}}</ref>. Recent longitudinal follow-up of these patients has confirmed previously reported findings <ref name="Fryzek2007">{{cite journal | author=Fryzek JP, Holmich L, McLaughlin JK, Lipworth L, Tarone RE, Henriksen T, Kjoller K, Friis S | title=A Nationwide Study of Connective Tissue Disease and Other Rheumatic Conditions Among Danish Women With Long-Term Cosmetic Breast Implantation.| journal= Ann Epidemiol| year=2007 | id= PMID 17321754}}</ref><p>




Several studies have established that women who undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. For example, two large studies of plastic surgery patients found a decreased [[standardized mortality ratio]] in both breast implant and other plastic surgery patients, but an increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled in one study and not in the other, but the authors speculated that there could potentially be differences in smoking that might contribute to the higher lung cancer deaths among women with implants.<ref name=Brinton2006>{{cite journal | author=Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN | title=Mortality rates among augmentation mammoplasty patients: an update | journal=Epidemiology | year=2006 | pages=162-9 | volume=17 | issue=2 | id=PMID 16477256}}</ref><ref name=Mclaughlin2006>{{cite journal | author=McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O| title=Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study| journal=J Natl Cancer Inst. | year=2006 | pages=557-60 | volume=98 | issue=8 | id=PMID 16622125}}</ref>Another large study with long-term follow-up of nearly 25,000 Canadian women with implants reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind.<ref name="Villenueve2006">{{cite journal | author=Villenueve PJ, et. al | title=Mortality among Canadian Women with Cosmetic Breast Implants. | journal=Am J Epidemiol| year=2006 | month=June| id=PMID 16777929 }}</ref><p>
Several studies have established that women who undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. For example, two large studies of plastic surgery patients found a decreased [[standardized mortality ratio]] in both breast implant and other plastic surgery patients, but an increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled in one study and not in the other, but the authors speculated that there could potentially be differences in smoking that might contribute to the higher lung cancer deaths among women with implants.<ref name=Brinton2006>{{cite journal | author=Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN | title=Mortality rates among augmentation mammoplasty patients: an update | journal=Epidemiology | year=2006 | pages=162-9 | volume=17 | issue=2 | id=PMID 16477256}}</ref><ref name=Mclaughlin2006>{{cite journal | author=McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O| title=Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study| journal=J Natl Cancer Inst. | year=2006 | pages=557-60 | volume=98 | issue=8 | id=PMID 16622125}}</ref> <p>


Another large study of nearly 25,000 Canadian women with implants reported significantly fewer breast cancers and most other cancers compared with the general population. The study also reported higher suicide rates in implant patients. <ref name="Villenueve2006">{{cite journal | author=Villenueve PJ, et. al | title=Mortality among Canadian Women with Cosmetic Breast Implants. | journal=Am J Epidemiol| year=2006 | month=June| id=PMID 16777929 }}</ref><p>
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In 2001 a study suggested an increase in [[fibromyalgia]] among women with extracapsular silicone gel leakage, compared to women whose implants were not broken or leaking outside the capsule.<ref name="Brown2001">{{cite journal | author=Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS | title=Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women | journal=J Rheumatol | year=2001 | pages=996-1003 | volume=28 | issue=5 | id=PMID 11361228 [http://www.fda.gov/cdrh/breastimplants/extracapstudy.html FDA Summary]}}</ref> This association has not repeated in a number of related studies,<ref name=Lipworth>{{cite journal | author=Lipworth L, Tarone RE, McLaughlin JK.| title=Breast implants and fibromyalgia: a review of the epidemiologic evidence.| journal=Ann Plast Surg. | year=2004 | pages=284-7| volume=52 | issue=3 | id=PMID 15156983}}</ref> and the US-FDA concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants."<ref>[http://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html#1]</ref><p>


⚫
In 2001 a study suggested an increase in [[fibromyalgia]] among women with silicone gel leakage outside the scar capsule, compared to women whose implants were not broken or leaking outside the capsule.<ref name="Brown2001">{{cite journal | author=Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS | title=Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women | journal=J Rheumatol | year=2001 | pages=996-1003 | volume=28 | issue=5 | id=PMID 11361228 [http://www.fda.gov/cdrh/breastimplants/extracapstudy.html FDA Summary]}}</ref>
⚫
While there is a general international consensus that silicone implants have not been shown to cause systemic illness, excluding the possibility that a small group of patients may become ill through (as yet) unknown mechanisms may prove difficult. As the US-FDA notes "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [http://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html]<p>

⚫
While the regulatory agencies of several countries have agreed that research does not conclude that silicone implants cause systemic illness, there is agreement about the lack of long-term studies of the impact of leaking silicone on health. As the US-FDA notes "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [http://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html]<p>

⚫
=== Incision types ===

⚫
Breast implants for augmentation may be placed via various types of incisions:
⚫
* '''Inframammary''' - an incision is placed below the breast in the infra-mammary fold (IMF). This incision is the most common approach and affords maximum access for dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required.
⚫
* '''Periareolar''' - an incision is placed along the areolar border. This incision provides an optimal approach when adjustments to the IMF position or mastopexy (breast lift) procedures are planned. The incision is generally placed around the inferior half, or the medial half of the areola's circumference. Larger silicone gel implants are difficult to place via this incision.
⚫
* '''Transaxillary''' - an incision is placed in the armpit and the dissection tunnels medially. This approach allows implants to be placed with no visible scars on the breast. Transaxillary procedures can be performed with or without an endoscope (tiny lighted camera).
⚫
* '''Transumbilical (TUBA)''' - a less common technique where an incision is placed in the navel and dissection tunnels superiorly. This approach enables implants to be placed with no visible scars on the breast, but makes appropriate dissection and implant placement more difficult. Transumbilical procedures may be performed bluntly or with an endoscope (tiny lighted camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell during blunt insertion.
⚫
* '''Transabdominoplasty (TABA)''' - procedure similar to TUBA, where the implants are tunneled up from the abdomen into bluntly dissected pockets while a patient is simultaneously undergoing an abdominoplasty procedure.

⚫
=== Implant pocket placement ===

⚫
The placement of implants is described in relation to the pectoralis major muscle.
⚫
* '''Subglandular'''- implant between the breast tissue and the pectoralis muscle. This position closely resembles the plane of normal breast tissue and is felt by many to achieve the most aesthetic results. The subglandular position in patients with thin soft-tissue coverage is most likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates are also slightly higher with this approach
⚫
* '''Subfascial'''- the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated, but proponents believe the thin vascularized fascia may help with coverage and sustaining positioning of the implant.
⚫
* '''Subpectoral''' ("dual plane") - the implant is placed underneath the pectoralis major muscle after releasing the inferior muscular attachments. As a result, the implant is partially beneath the pectoralis in the upper pole, while the lower half of the implant is in the subglandular plane. This is the most common technique in North America and achieves maximal upper implant coverage while allowing expansion of the lower pole. Capsular contracture rates have been lower after widespread adoption of this technique.
⚫
* '''Submuscular'''- the implant is placed below the pectoralis without release of the inferior origin of the muscle. Total muscular coverage may be achieved by releasing the lateral chest wall muscles (seratus and/or pectoralis minor) and sewn to the pectoralis major. This technique is most commonly used for maximal coverage of implants used in breast reconstruction.


== Complications ==
== Complications ==
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=== Rupture ===
=== Rupture ===
[[Image:Ruptured_implant.JPG|thumb|250px|Ruptured silicone implant with removed capsule]]
[[Image:Ruptured Implants2 anonymous.jpg|thumb|250px|Extracapsular rupture - Single lumen silicone implants ruptured a few years before their removal in 2004.]]

[[Image:Ruptured Implants2 anonymous.jpg|thumb|250px|Ruptured silicone implant.]]
[[Image:Ruptured_implant.JPG|thumb|250px|Intracapsular rupture - with capsule created by the body to wall off (silicone implant) foreign object]]


Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[http://www.fda.gov/cdrh/breastimplants/]<p>
Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[http://www.fda.gov/cdrh/breastimplants/]<p>
Line 109: Line 104:


=== Capsular contracture ===
=== Capsular contracture ===
[[Image:BreastImplantSilicon(picture2).jpg|thumb|250px|High grade (Baker IV) capsular contracture in the right breast around a subglandular gel implant.]]
[[Image:BreastImplantSilicon(picture2).jpg|thumb|250px|Grade IV capsular contracture in the right breast of a 29-year-old woman, seven years after subglandular placement of 560cc silicone gel-filled breast implants.]]


Capsules of tightly-woven collagen fibers form as an [[immune response]] around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. [[Capsular contracture]] occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma.Capsular contracture may happen again after this additional surgery.<p>
Capsules of tightly-woven collagen fibers form as an [[immune response]] around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. [[Capsular contracture]] occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma.Capsular contracture may happen again after this additional surgery.<p>
Methods which have reduced capsular contracture include submuscular implant placement, using textured<ref name="Barnsley2006">{{cite journal | author=Barnsley GP| title= Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: a meta-analysis of randomized controlled trials. | journal=Plast Reconstr Surg. | year=2006 | pages=2182-90| volume=117 | issue=7 | id=PMID 16772915}}</ref><ref name="Wong2006">{{cite journal | author=Wong CH, Samuel M, Tan BK, Song C.| title= Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: a systematic review| journal=Plast Reconstr Surg. | year=2006 | pages=1224-36| volume=118 | issue=5 | id=PMID 17016195}}</ref> or polyurethane-coated implants,<ref name="Handel2006">{{cite journal | author=Handel N, et al| title= Long-term safety and efficacy of polyurethane foam-covered breast implants. | journal=Aesth. Surg Journal | year=2006 | month=may | pages=265-74| volume=26 | issue=3 |}}</ref> limiting handling of the implants and skin contact prior to insertion<ref name="Mladick1993">{{cite journal | author=Mladick RA| title= "No-touch" submuscular saline breast augmentation technique. | journal=Aesth. Surg Journal | year=1993 | pages=183-92| volume=17 | issue=3 | id= PMID 8213311 }}</ref> and irrigation with triple-antibiotic solutions.<ref name="Adams2006">{{cite journal | author=Adams WP jr., et al| title= Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. | journal=Plast Reconstr Surg. | year=2006 | pages=30-36 | volume=117 | issue=1 | id=PMID 16404244}}</ref> <p>
Correction of capsular contracture may require surgical removal or release of the capsule or removal (and possible replacement) of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), was once a common maneuver for treating hard capsules; implant makers now warn against the procedure because it can cause implant rupture. Although there is no agreement on effectiveness, nonsurgical methods of treating capsules include external ultrasound,<ref name="Planas2001">{{cite journal | author=Planas J| title= Five-year experience on ultrasonic treatment of breast contractures. | journal=Aesthetic Plast Surg. | year=2001| pages=89-93 | volume=25 | issue=2 | id=PMID 11349308}}</ref> treatment with [[leukotriene]] pathway inhibitors (Accolate, Singulair),<ref name="Schlesinger2002">{{cite journal | author=Schlesinger SL, wt al| title= Zafirlukast (Accolate): A new treatment for capsular contracture. | journal=Aesthetic Plast Surg. | year=2002| pages=329-336| volume=22 | issue=4}}</ref> and pulsed electromagnetic field therapy.<ref name="Silver1982">{{cite journal | author=Silver H| title= Reduction of capsular contracture with two-stage augmentation mammaplasty and pulsed electromagnetic energy (Diapulse therapy). | journal=Plast Reconstr Surg. | year=1982| pages=802-8 | volume=69 | issue=5 | id=PMID 7071225}}</ref> <P>
Correction of capsular contracture may require surgical removal or release of the capsule or removal (and possible replacement) of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include external ultrasound,<ref name="Planas2001">{{cite journal | author=Planas J| title= Five-year experience on ultrasonic treatment of breast contractures. | journal=Aesthetic Plast Surg. | year=2001| pages=89-93 | volume=25 | issue=2 | id=PMID 11349308}}</ref> treatment with [[leukotriene]] pathway inhibitors (Accolate, Singulair),<ref name="Schlesinger2002">{{cite journal | author=Schlesinger SL, wt al| title= Zafirlukast (Accolate): A new treatment for capsular contracture. | journal=Aesthetic Plast Surg. | year=2002| pages=329-336| volume=22 | issue=4}}</ref> and pulsed electromagnetic field therapy.<ref name="Silver1982">{{cite journal | author=Silver H| title= Reduction of capsular contracture with two-stage augmentation mammaplasty and pulsed electromagnetic energy (Diapulse therapy). | journal=Plast Reconstr Surg. | year=1982| pages=802-8 | volume=69 | issue=5 | id=PMID 7071225}}</ref> <P>


=== Scarring ===
=== Scarring and hypotrophic scarring ===


A common complication of breast implants is [[scarring]], including hypotrophic scarring. Although scarring is a common complication of surgery, the rate of 6-7% reported for augmentation patients by the two main manufacturers in the world, Allergan and Mentor,
All surgical procedures on the breast leave scars. Scar quality is determined by factors including a patient's ethnicity, tissue quality, wound tension, suture material, tissue trauma from surgery, smoking, and an individuals propensity for favorable wound healing. While most breast augmentation incisions heal well, a rate of 6-7% of unfavorable scarring was reported for primary augmentation patients in US-FDA clinical trials
[http://www.fda.gov/cdrh/pdf3/p030053d.pdf] [http://www.fda.gov/cdrh/pdf2/P020056d.pdf].
[http://www.fda.gov/cdrh/pdf3/p030053d.pdf] [http://www.fda.gov/cdrh/pdf2/P020056d.pdf] is a notable complication for a cosmetic procedure.


===Chronic pain and changes in nipple and breast sensitivity ===
===Chronic pain and changes in nipple and breast sensitivity ===
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This altered sensitivity can be temporary or permanent and may affect sexual response or the ability to nurse a baby.<p>
This altered sensitivity can be temporary or permanent and may affect sexual response or the ability to nurse a baby.<p>


===Implant Extrusion and Tissue Necrosis===
===Extrusion===
Compromise of blood supply as a result of surgical procedures may lead to skin loss or breast tissue necrosis (death). Unstable or weakened tissue covering may result in subsequent extrusion of the breast implant through the skin. Implant extrusion and tissue necrosis are rare in breast augmentation patients, but may occurs in up to 1-2% of reconstruction patients using implants.[http://www.fda.gov/cdrh/pdf2/P020056e.pdf[http://www.fda.gov/cdrh/pdf2/P020056d.pdf]
Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin. According to the two main implant manufacturers, Allergan and Mentor, extrusion occurs for 1-2% of reconstruction patients, and is somewhat less common with augmentation patients.
Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.[http://www.fda.gov/cdrh/pdf2/P020056e.pdf][http://www.fda.gov/cdrh/pdf3/p030053e.pdf] Procedures which combine simultansous breast augmentation with [[mastopexy]] (breast lift) techniques carry higher rates of implant loss or wound breakdown then either procedure alone.<p>
[http://www.fda.gov/cdrh/pdf2/P020056e.pdf][http://www.fda.gov/cdrh/pdf2/P020056d.pdf]
Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

===Necrosis===
Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal. According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implant reconstruction patients (2%) than augmentation patients (less than 1%).[http://www.fda.gov/cdrh/pdf2/P020056e.pdf][http://www.fda.gov/cdrh/pdf3/p030053e.pdf] A permanent scar may form. <p>


==Platinum==
==Platinum==


[[Platinum]] is a [[catalyst]] used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients. <ref name="arepelli2003">{{cite journal | author=Arepelli S, ''et al.'' | title=Allergic reactions to platinum in silicone breast implants. | journal=J Long-Term Effects Medical Implants | year=2002 | pages=299-306 | id=PMID 12627791 }}</ref> </p>
[[Platinum]] is a [[catalyst]] used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients. <ref name="arepelli2003">{{cite journal | author=Arepelli S, ''et al.'' | title=Allergic reactions to platinum in silicone breast implants. | journal=J Long-Term Effects Medical Implants | year=2002 | pages=299-306 | id=PMID 12627791 }}</ref> </p>
In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states ''in vivo''. <ref name="AnalChem2006-Lykissa">{{cite journal | author = Lykissa E.D. and Maharaj S.V.M. | year = 2006 | month = April | title = Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS | journal = Anal. Chem. | volume = | issue = | pages = | id =(due publication May 2006) | url =http://pubs.acs.org/cgi-bin/abstract.cgi/ancham/asap/abs/ac0514016.html | accessdate =2006-04-06}}</ref> A letter from the editors of the publishing journal, ''Analytical Chemistry'', subsequently expressed concern over the research's experimental design and urged the journal's readers to "use caution in evaluating the conclusions drawn in the paper." <ref>[http://pubs.acs.org/cen/news/84/i31/8431notw5.html]</ref>The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women. <ref>[http://www.fda.gov/cdrh/breastimplants/platinum.html]</ref>
In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states ''in vivo''. <ref name="AnalChem2006-Lykissa">{{cite journal | author = Lykissa E.D. and Maharaj S.V.M. | year = 2006 | month = April | title = Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS | journal = Anal. Chem. | volume = | issue = | pages = | id =(due publication May 2006) | url =http://pubs.acs.org/cgi-bin/abstract.cgi/ancham/asap/abs/ac0514016.html | accessdate =2006-04-06 (Web)}}</ref> A letter from the editors of the publishing journal, ''Analytical Chemistry'', subsequently expressed concern over the research's experimental design and urged the journal's readers to "use caution in evaluating the conclusions drawn in the paper." <ref>[http://pubs.acs.org/cen/news/84/i31/8431notw5.html]</ref>The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women. <ref>[http://www.fda.gov/cdrh/breastimplants/platinum.html]</ref>


== Concerns with breast cancer screening and treatment in patients with breast implants ==
== Concerns with breast cancer screening and treatment in patients with breast implants ==

Revision as of 04:55, 6 March 2007

A breast implant is a prosthesis used to enlarge the size of a woman's breasts (known as breast augmentation) for cosmetic reasons, to reconstruct the breast (e.g. after a mastectomy or to correct genetic deformities), or as an aspect of male-to-female sex reassignment surgery. According to the American Society of Plastic Surgeons, breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In 2005, 291,000 breast augmentation procedures were performed.[1]

There are two primary types of breast implants: saline filled and silicone gel filled implants. Saline implants have a silicone elastomer shell filled with sterile saline liquid. Silicone gel implants have a silicone shell filled with a viscous silicone gel.

History

Implants have been used since 1895 to augment the size or shape of women's breasts. The earliest known implant was attempted by Czerny, using a woman's own adipose tissue (from a lipoma, a benign growth, on her back).[2] Gersuny tried paraffin injections in 1889, with disastrous results. Subsequently, in the early to mid-1900s, a number of other substances were tried, including ivory, glass balls, ground rubber, ox cartilage, Terylene wool, gutta-percha, Dicora, polyethylene chips, polyvinyl alcohol-formaldehyde polymer sponge (Ivalon), Ivalon in a polyethylene sac, polyether foam sponge (Etheron), polyethylene tape (Polystan) or strips wound into a ball, polyester (polyurethane foam sponge) Silastic rubber, and teflon-silicone prostheses.[6] In recent history, various creams and medicaments have been used in attempts to increase bust size, and Berson in 1945 and Maliniac in 1950 performed a flap-based augmentation by rotating the patients chest wall tissue into the breast to add volume. Various synthetics were used throughout the 1950s and 1960s, including silicone injections, which an estimated 50,000 women received.[3] Development of silicone granulomas and hardening of the breasts were in some cases so severe that women needed to have mastectomies for treatment. Women sometimes seek medical treatment for complications up to 30 years after receiving this type of injection.

Indications

Clinical indications for the use of breast implants are for breast reconstruction, sex reassignment surgery, and for abnormalities that affect the shape and size of the breast. In some countries health insurers will reimburse insertion of breast implants only for these indications[citation needed]. Non-clinical indications (the most common reasons) are cosmetic.

Patient characteristics

Patients seeking breast augmentation are usually younger, healthier, and from higher socio-economic status than the population at large.[4] Many of these patients have greater distress about their appearance, and have been diagnosed with body dysmorphic disorder, a condition defined as “a preoccupation with an imagined or slight defect in appearance that leads to significant impairment in functioning.” [5] This psychiatric problem has been found to be unresponsive to plastic surgery and effectively treated by psychotherapy. [6]

Post-operative surveys on mental health and quality of life issues have shown short-term improvement in confidence regarding the appearance of the breasts, but after six months there was no improvement in self-esteem or general self-confidence. [7] When the two major implant manufacturers objectively compared self-esteem, quality of life, and self-concepts just before augmentation and 3-4 years afterwards, they found no improvement in self-concept, confidence, mental health, or quality of life on most measures; the one improvement was in feeling more sexually attractive [8] [9] However, other studies have found that most patients report being satisfied with their implants even when they have required reoperation for complications or aesthetic reasons.[10]

Types of implants

Saline implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion[11] with the goal of being surgically placed via smaller incisions. These original devices had a high failure rate and were discontinued in the early 1970s [citation needed]. The current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have high failure rates in vivo.[12]

Saline-filled implants are the most common implant used in the United States due to restrictions on silicone implants, but are rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, plastic surgeons believe that silicone gel implants are the superior device. In patients with more breast tissue, however, saline implants can look very similar to silicone gel.

Silicone gel implants

Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962. Silicone implants are generally described in terms of five generations which segregates common characteristics of manufacturing techniques.

  • First generation

The Cronin-Gerow implants were made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch on the posterior shell.[13] They were firm and had a "teardrop" anatomic shape.

  • Second generation

In response to surgeons' requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner gel and thinner shells. These implants had a greater tendency to rupture and leak, or "bleed" silicone through the porous shell, and complications such as capsular contracture were also quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s. Another development in the 1970s was a polyurethane foam coating on the implant shell which was effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.[14] A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify removal of the devices. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States.[15] Second-generation implants also included various "double lumen" designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction.

  • Third & Fourth generation

Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles and were elastomer-coated to decrease gel bleed, and a filled with thicker, more cohesive gel. These implants are sold under restricted conditions in the U.S. and Canada, and are widely used in other countries. The increased cohesion of the gel filler reduces leakage of the gel compared to earlier devices. A variety of both round and tapered anatomic shapes are available. Anatomic shaped implants are uniformly textured to reduce rotation, while round devices are available in smooth or textured surfaces.

  • Fifth generation

Evaluation of "gummy bear" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been used longer in other countries. Plastic surgeons believe that the greater gel cohesion in these implants is likely to significantly reduce the possibility of silicone migration. Early reports of these devices have shown significant improvements in safety and efficacy, over the older implants. [16][17][18]

Systemic illness and disease

Since the early 1990s, a number of independent systemic (comprehensive) reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no conclusive evidence of a causal link between the implantation of silicone breast implants and systemic disease.[7][8][9][10][11]

Thousands of women still claim that they have become ill from their implants. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [19] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

As studies have followed women with implants for a longer period of time, more data are available on systemic diseases as well as autoimmune symptoms. A 2004 Danish study reported that women who had breast implants for an average of 19 years were no more likely to be diagnosed with classic autoimmune diseases than breast reduction patients, but were "significantly more likely" to report "fatigue", "Raynaud-like symptoms (white fingers and toes when exposed to cold)", and "memory loss" and other "cognitive symptoms", compared to women of the same age in the general population. [20]

Several studies have established that women who undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. For example, two large studies of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but an increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled in one study and not in the other, but the authors speculated that there could potentially be differences in smoking that might contribute to the higher lung cancer deaths among women with implants.[21][22]

Another large study of nearly 25,000 Canadian women with implants reported significantly fewer breast cancers and most other cancers compared with the general population. The study also reported higher suicide rates in implant patients. [23]

In 2001 a study suggested an increase in fibromyalgia among women with silicone gel leakage outside the scar capsule, compared to women whose implants were not broken or leaking outside the capsule.[24] While the regulatory agencies of several countries have agreed that research does not conclude that silicone implants cause systemic illness, there is agreement about the lack of long-term studies of the impact of leaking silicone on health. As the US-FDA notes "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [12]

Incision types

Breast implants for augmentation may be placed via various types of incisions:

  • Inframammary - an incision is placed below the breast in the infra-mammary fold (IMF). This incision is the most common approach and affords maximum access for dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required.
  • Periareolar - an incision is placed along the areolar border. This incision provides an optimal approach when adjustments to the IMF position or mastopexy (breast lift) procedures are planned. The incision is generally placed around the inferior half, or the medial half of the areola's circumference. Larger silicone gel implants are difficult to place via this incision.
  • Transaxillary - an incision is placed in the armpit and the dissection tunnels medially. This approach allows implants to be placed with no visible scars on the breast. Transaxillary procedures can be performed with or without an endoscope (tiny lighted camera).
  • Transumbilical (TUBA) - a less common technique where an incision is placed in the navel and dissection tunnels superiorly. This approach enables implants to be placed with no visible scars on the breast, but makes appropriate dissection and implant placement more difficult. Transumbilical procedures may be performed bluntly or with an endoscope (tiny lighted camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell during blunt insertion.
  • Transabdominoplasty (TABA) - procedure similar to TUBA, where the implants are tunneled up from the abdomen into bluntly dissected pockets while a patient is simultaneously undergoing an abdominoplasty procedure.

Implant pocket placement

The placement of implants is described in relation to the pectoralis major muscle.

  • Subglandular- implant between the breast tissue and the pectoralis muscle. This position closely resembles the plane of normal breast tissue and is felt by many to achieve the most aesthetic results. The subglandular position in patients with thin soft-tissue coverage is most likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates are also slightly higher with this approach
  • Subfascial- the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated, but proponents believe the thin vascularized fascia may help with coverage and sustaining positioning of the implant.
  • Subpectoral ("dual plane") - the implant is placed underneath the pectoralis major muscle after releasing the inferior muscular attachments. As a result, the implant is partially beneath the pectoralis in the upper pole, while the lower half of the implant is in the subglandular plane. This is the most common technique in North America and achieves maximal upper implant coverage while allowing expansion of the lower pole. Capsular contracture rates have been lower after widespread adoption of this technique.
  • Submuscular- the implant is placed below the pectoralis without release of the inferior origin of the muscle. Total muscular coverage may be achieved by releasing the lateral chest wall muscles (seratus and/or pectoralis minor) and sewn to the pectoralis major. This technique is most commonly used for maximal coverage of implants used in breast reconstruction.

Complications

Local complications that can occur with breast implants include post-operative bleeding (hematoma), fluid collections (seroma), surgical site infection, breast pain, alterations in nipple sensation, interference with breast feeding, visible wrinkling, asymmetric appearance, wound dehiscence (with potential implant exposure), thinning of the breast tissue, and synmastia (disruption of the natural plane between breasts).

Rupture

Extracapsular rupture - Single lumen silicone implants ruptured a few years before their removal in 2004.
Intracapsular rupture - with capsule created by the body to wall off (silicone implant) foreign object

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[13]

The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation. Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [14] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.

Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture; according to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [25] For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery and recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [15]. Other countries have not endorsed routine MRI screening, and taken the position that MRI be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.[16]

In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study. [26] However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. MRI data from the US-FDA required "core" studies of contemporary implants has demonstrated low rupture rates (<2%) within the first 3-4 years after implantation for single lumen silicone implants, and will continue to be followed longitudinally to better characterize rupture rate.[17]

The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of at between 8% to 15% at or around a decade.[27][28][29] This represented a 15-30% silent rupture risk for individual patients. The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less, at a median age of six years.[30]

When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae [31] in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy [32](enlarged lymph glands in the armpit area). [18]

The specific risk and treatment of extracapsular silicone gel is still controversial. Plastic surgeons agree that it is difficult to remove, but there is disagreement about the health effects.

Capsular contracture

File:BreastImplantSilicon(picture2).jpg
Grade IV capsular contracture in the right breast of a 29-year-old woman, seven years after subglandular placement of 560cc silicone gel-filled breast implants.

Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma.Capsular contracture may happen again after this additional surgery.

Correction of capsular contracture may require surgical removal or release of the capsule or removal (and possible replacement) of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), was once a common maneuver for treating hard capsules; implant makers now warn against the procedure because it can cause implant rupture. Although there is no agreement on effectiveness, nonsurgical methods of treating capsules include external ultrasound,[33] treatment with leukotriene pathway inhibitors (Accolate, Singulair),[34] and pulsed electromagnetic field therapy.[35]

Scarring and hypotrophic scarring

A common complication of breast implants is scarring, including hypotrophic scarring. Although scarring is a common complication of surgery, the rate of 6-7% reported for augmentation patients by the two main manufacturers in the world, Allergan and Mentor, [19] [20] is a notable complication for a cosmetic procedure.

Chronic pain and changes in nipple and breast sensitivity

Feeling in the nipple and breast can change after implant surgery. Changes include intense sensitivity, chronic breast pain, and no feeling in the nipple or breast for months or years after surgery.

In their booklets for patients, Allergan and Mentor report that within the first three years, between 2-8% of augmentation patients report moderate to severe chronic breast pain, an additional 1-2% report moderate to severe breast sensitivity changes, and 3-10% report moderate to severe nipple complications such as loss of sensation. [21] [22] [23] These are similar for silicone gel or saline breast implants, but the longer-term data on saline implants indicates that chronic breast pain is reported by 17% of women within five years.

This altered sensitivity can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

Extrusion

Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin. According to the two main implant manufacturers, Allergan and Mentor, extrusion occurs for 1-2% of reconstruction patients, and is somewhat less common with augmentation patients. [24][25] Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

Necrosis

Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal. According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implant reconstruction patients (2%) than augmentation patients (less than 1%).[26][27] A permanent scar may form.

Platinum

Platinum is a catalyst used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients. [36]

In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states in vivo. [37] A letter from the editors of the publishing journal, Analytical Chemistry, subsequently expressed concern over the research's experimental design and urged the journal's readers to "use caution in evaluating the conclusions drawn in the paper." [38]The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women. [39]

Concerns with breast cancer screening and treatment in patients with breast implants

The presence of radio-opaque breast implants may interfere with the sensitivity of screening mammography. Specialized radiographic techniques where the implant is manually displaced (Eklund views) may improve this somewhat, but approximately 1/3 of the breast is still not adequately visualized with a resultant increase in false-negative mammograms.[40] A number of studies looking at breast cancers in women with implants have found no significant difference in stage of disease at time of diagnosis, and prognosis appears to be similar in both groups with augmented patients not a higher risk for subsequent cancer recurrence or death.[41][42] Conversely, the use of implants for reconstruction after mastectomy for breast cancer also appears not to have a negative affect on cancer-related mortality.[43]

An observation that patients with implants are more often diagnosed with palpable tumors (but not larger ones) suggest that tumors of equal size may be more easily palpated in augmented patients, and this may compensate somewhat for the potential impairment of mammography.[44] This palpability is due to thinning of the breast by compression, innately smaller breasts a priori, and that the implant serves as a base against which the mass may be differentiated.[45]

The presence of a breast implant does not influence the ability for breast conservation (lumpectomy) surgery for women who subsequently develop breast cancer, and does not interfere with delivery of external beam radiation (XRT) treatments that may be required.[46] Fibrosis of breast tissue after XRT is common and an increase in capsular contracture rates would be expected.

Repair or revision surgery

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (reoperations) over the course of their lives. Reasons for reoperations include capsular contracture, wrinkling, asymmetry, rupture/deflation, implant malposition and other local complications.[47] Reoperation rates are more frequent in breast reconstruction cases, particularly when patients have received XRT. A recent study found that 1 in 3 women getting breast implants for reconstruction needed a reoperation within five years, and about 1 in 8 women getting breast implants for augmentation needed a reoperation within five years. [48]

It appears that reoperation rates can be improved by more carefully matching individual patients' soft-tissue characteristics to the type and size of implants used. Using appropriate device selection and proper technique, reoperation rates at up to seven years follow up have been reported as low as 3%,[49][50] as compared with the 20 percent reoperation rate at 3 years in the most recent Food and Drug Administration study.

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