Jump to content

Essure: Difference between revisions

From Wikipedia, the free encyclopedia
Browse history interactively
← Previous editNext edit →
Content deleted Content added
VisualWikitext
Line 74: Line 74:
*Hair loss or changes
*Hair loss or changes
*Hair growth in new places
*Hair growth in new places
*Problems
*Depression suicidal thoughts
*Depression suicidal thoughts
*Brain shocks
*Brain shocks

Revision as of 05:29, 17 April 2013

Essure
Background
TypeSterilization
First use2002
Failure rates (first year, after occlusion)
Perfect use0.2%
Typical use0.2%
Usage
Duration effectPermanent
ReversibilityIrreversible
User remindersAdditional methods until 3 month check by hysterosalpingogram
Clinic reviewNone
Advantages and disadvantages
STI protectionNo
BenefitsPermanent contraception

Essure is a permanent, non-surgical transcervical sterilization procedure for women developed by Conceptus Inc. It was approved for use in the United States on November 4, 2002.[1]

Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic bilateral tubal ligation.[2]

Procedure

Small, flexible inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The insert contains inner polyethylene terephthalate fibers to induce benign fibrotic reaction and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil.[3] Once in place, the device is designed to elicit tissue growth in and around the insert to form over a period of three months an occlusion or blockage in the fallopian tubes; the tissue barrier formed prevents sperm from reaching an egg.

Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required.

Similar to some other methods of birth control, initially additional forms of birth control must be continued for 3 months[2] to prevent pregnancy until the method's effectiveness can be confirmed.

Follow-up

For the Essure method, three months after insertion a physician performs an x-ray test called a hysterosalpingogram[4] to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control.[1] A contrast agent (dye) is injected through the cervix, and an x-ray technologist takes photos of the Essure coils to ensure that they are in place.

Efficacy

Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up, with zero pregnancies reported in clinical trials.[5][6]

The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)".[7] Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.[1]

Cautions and warnings

The inserts do not prevent the transmission of sexually transmitted diseases. The procedure takes about 10 minutes[8] for a trained physician to perform and can be performed in a physician's office. General anesthesia is not required. Unlike many temporary methods of birth control, the Essure inserts do not contain or release hormones.

The inserts are made from polyester fibers, nickel-titanium and stainless steel and are safe to use with MRI equipment. The Essure procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed.[9]

Additional birth control must be used for three months after procedure.[7][10]

Risks

  • Perforation, expulsion, or other unsatisfactory location of the insert
  • Pregnancy and increased risk of ectopic pregnancy
  • Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6–8 weeks due to changing birth control methods to a non-hormonal solution
  • Nausea/vomiting
  • Vasovagal response (fainting)
  • Allergic reaction to the materials
  • Fevers
  • Sharp stabbing pains
  • Back pain, Neck pain, Spine pain, Joint pain, Chest pain
  • Fatigue/loss of energy
  • Headaches or migraines
  • Metallic taste in mouth
  • Dizziness
  • Tingling sensations
  • Numbness
  • Weight gain or loss
  • Severe bloating
  • Swelling of legs or feet
  • Leg pains
  • Hair loss or changes
  • Hair growth in new places
  • Problems
  • Depression suicidal thoughts
  • Brain shocks
  • Perforations from the coils
  • Coil migrations
  • Broken coils
  • Period stops
  • Nerve pain
  • Ovarian cysts
  • Uterine cysts
  • Fallopian tube cysts
  • More than two Essure coils inserted
  • Coils becoming embedded in other tissues
  • PTSD
  • Vitamin D deficient
  • Teeth issues
  • Heartburn
  • Cloudiness, Forgetfulness
  • UTI’s, bladder infections, Candida or Yeast infections
  • Insomnia
  • Heart palpitations
  • Fluttering feeling or spasms
  • Anxiety, Panic attack, Mood swings
  • Pregnancy
  • Pulmonary embolism
  • Bacterial vaginosis
  • Constant spotting
  • Foul smell or discharge
  • Bowel issues
  • Endometriosis, Adenomyosis
  • Miscarriage
  • Autoimmune disorders, Chronic Inflamation Syndrom
  • Chemical and food sensitivities
  • Hives, rashes, cysts, boils, acne
  • Anemia
  • Hot flashes
  • Adhesions, Organs fusing to other organs
  • Breast pain
  • Hyperthyoidism, Hypothyroidism
  • Low or no sex drive
  • Irregular periods with breakthrough bleeding
  • Blood clots
  • Extreme pain

References

  1. ^ a b c "Essure[[Trademark|™]] System - P020014". US Food and Drug Administration. 06/29/2009. Retrieved 2011-05-21. {{cite web}}: Check date values in: |date= (help); URL–wikilink conflict (help)
  2. ^ a b Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1016/j.fertnstert.2009.02.080, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1016/j.fertnstert.2009.02.080 instead.
  3. ^ Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007 Jun;114(6):763-6.
  4. ^ "Essure Confirmation Test". Conceptus Inc. Retrieved 2011-05-30.
  5. ^ control methodsbyConceptus/Understanding/ClinicalTesting/tabid/58/Default.aspx "Clinical Testing". Essure. Conceptus. Retrieved 2006-12-12. {{cite web}}: Check |url= value (help) [dead link‍]
  6. ^ Smith RD (2010). "Contemporary hysteroscopic methods for female sterilization". Int J Gynaecol Obstet. 108 (1): 79–84. doi:10.1016/j.ijgo.2009.07.026. PMID 19716128. {{cite journal}}: Unknown parameter |month= ignored (help)
  7. ^ a b "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Archived from the original (PDF) on 2006-11-11. Retrieved 2006-12-12.
  8. ^ http://www.marketwatch.com/story/conceptusr-to-promote-gynecare-thermachoicer-to-us-physician-offices-2010-11-10?reflink=MW_news_stmp
  9. ^ "Doctors Confirm First Successful Essure Tubal Ligation Reversal". 2008-10-08. Retrieved 2010-02-15., referring to Dr. William A.C. Greene Jr. and Dr. Wendell Turner at Lakeshore Surgical Center
  10. ^ Hurskainen R, Hovi SL, Gissler M; et al. (2009). "Hysteroscopic tubal sterilization: a systematic review of the Essure system". Fertil. Steril. 94 (1): 16–19. doi:10.1016/j.fertnstert.2009.02.080. PMID 19409549. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)

'''The meeting minutes between Concepts and the FDA regarding PMA' http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3881t1.doc 

Information regarding Nickel

Nickel warning removed from Essure label http://investor.conceptus.com/releasedetail.cfm?ReleaseID=596932 Implant Syndrome http://www.ehcd.com/Implant_Syndrome_070711.pdf Metal corrosion in the human body http://www.electrochem.org/dl/interface/sum/sum08/su08_p31-34.pdf Nickel compounds toxicity http://digitalfire.com/4sight/hazards/ceramic_hazard_nickel_compounds_toxicity_327.html Can I be allergic to a metal implant? http://orthopedics.about.com/od/orthopedicsinformation/f/metalallergy.htm A nickel for your thoughts http://www.worldoforthopedics.com/2010/02/a-nickel-for-your-thoughts/#more-154.........The Nickel and surgical implants http://www.nickelinstitute.org/en/HealthScienceEnvironmentalScienceAndSafeUse/ProductUseAdvisoryNotes/~/media/Files/HealthEnvironmentSafeUse/AdvisoryNotes/EN/AdvisoryNotesSurgicalA4rev.ashx FDA Talk about metal allergies http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070171.htm Nickel allergies symptoms and treatment http://www.steadyhealth.com/articles/Nickel_Allergy_Symptoms_and_Treatment_a885.html 

 Information on PET (polyethykene terephthalate)

Mesh implants in hernia repair http://www.facebook.com/home.php?#!/groups/Essureproblems/547628651935519/ Mirena PET reactions http://pennstatehershey.adam.com/content.aspx?productId=45&pid=45&gid=5106 PET http://www.plasticsmadesimple.com/DataSheets/PET_MSDS.pdf 

 Expulsion

Expulsion of coils even after 3 month HSG http://www.facebook.com/home.php?#!/groups/Essureproblems/544908338874217/ 

 Random Articles

Imperative to Warn: Disentangling the "Right to Know" from the "Need to Know" about Consumer Product Hazards http://www.facebook.com/home.php?#!/groups/Essureproblems/541316495900068/ Reversible contraceptive effect of the oviduct plug with nickel–titanium shape memory alloy and silicone rubber in rabbits http://www.facebook.com/home.php?#!/groups/Essureproblems/540778269287224/ Surgical aspects of removal of Essure microinsert http://www.facebook.com/home.php?#!/groups/Essureproblems/540777282620656/ Your Complete Guide to the Essure Procedure (2012).pdf http://www.facebook.com/home.php?#!/groups/Essureproblems/538052352893149/ Conceptus Essure DRAFT Instructions for Use L2133 Rev. A (06/12/02) http://www.facebook.com/home.php?#!/groups/Essureproblems/538015986230119/ Summary of Safety and Effectiveness Data http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdf How to search for Essure related articles on pubmed http://www.ncbi.nlm.nih.gov/pubmed?term=Essure Essure adverse events reported to the FDA so far..... http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&searchyear=&productcode=&productproblem=&devicename=&knumber=K&pmanumber=P&manufacturer=conceptus&brandname=essure&eventtype=&reportdatefrom=01%2F01%2F2002&reportdateto=06%2F29%2F2012&pagenum=10&key_count=518 Essure: Be careful what you wish for http://thirdcoastdigest.com/2008/05/essure-be-careful-what-you-wish-for/ Multimodality Imaging of the Essure Permanent Birth Control Device: Emphasis on Commonly Overlooked Abnormalities http://www.ajronline.org/content/196/5/W648.full.pdf+html Complications of implants http://www.ask.com/wiki/Implant_(medicine) Study of HSG imaging https://kb.osu.edu/dspace/bitstream/handle/1811/51903/Jaime_Hartley_Thesis.pdf?sequence=1 Use of intraoperative fluoroscopy during laparotomy to identify fragments of retained Essure microinserts: case report. http://www.ncbi.nlm.nih.gov/pubmed/?term=flouroscopy+essure+fragments FDA Public Health Notification: Unretrieved Device Fragments http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm What is chronic inflammation? http://www.womentowomen.com/inflammation/whatischronicinflammation.aspx The Medical Device Safety Act of 2009 http://www.nejm.org/doi/pdf/10.1056/NEJMe0902377 http://www.govtrack.us/congress/bills/111/hr1346 http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.1346: http://www.lexology.com/library/detail.aspx?g=6689b667-6b8c-444a-ab75-8cc0ea5dada5 Doctor admits Essure as problem http://www.justanswer.com/ob-gyn/636em-essure-procedure-performed-feb-2011.html MRI Safety and Essure http://mrisafety.com/safety_article.asp?subject=148 FDA compliance Activities for Medical Devices. Medical Device Premarket Approval and Postmarket Inspections http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ComplianceActivities/ucm295675.htm conceptus accelerates essure pma submission http://investor.conceptus.com/releasedetail.cfm?ReleaseID=252051 medical device definition. class explanations http://en.wikipedia.org/wiki/Medical_device overview: fda regulation of medical devices http://www.qrasupport.com/FDA_MED_DEVICE.html us patents http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6705323.PN.&OS=PN%2F6705323&RS=PN%2F6705323 protocols for in office hysteroscopic sterilization http://www.obgmanagement.com/Essure/pdf/October_2005.pdf essure instructions for use http://www.obgmanagement.com/Essure/pdf/October_2005.pdf one clinical trial exclusion criteria http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01221974 clinical trials http://clinicaltrials.gov/ct2/results?term=Essure&Search=Search pma approval and conditions http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014a.pdf post approval study 1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?c_id=112&t_id=367828 post approval study 2 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?t_id=405774&c_id=788#tt fact sheet complete immunity preemtion http://www.justice.org/cps/rde/xchg/justice/hs.xsl/2674.htm difference between drug and device preemption http://druganddevicelaw.blogspot.com/search?q=Medical+device+preemption preemption in medical device litigation http://www.thefederation.org/documents/24.Preemption%20Medical%20Device.pdf

Stub icon

This medical treatment–related article is a stub. You can help Wikipedia by expanding it.

Template:Essure horror stories Template:Essure survivor stories

Retrieved from "https://en.wikipedia.org/w/index.php?title=Essure&oldid=550760597"