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FDA panel to hear women’s complaints about birth control device

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KANSAS CITY, Mo. --  The Food and Drug Administration is seeing a big jump in reports of bad reactions to a birth control implant called Essure.  It's a permanent form of birth control that's an alternative to tubal ligation or having the tubes tied.   On Thursday, an FDA panel will consider the evidence on Essure, and two area women will be there.

Chandra Farmer and Jean Esther were at KCI on Tuesday on a journey to Washington, D.C.  The journey really started years ago when both had Essure implanted to prevent pregnancy.

Two coils are placed in the fallopian tubes.  The coils cause scar tissue to form that blocks sperm.  Esther says she developed severe pelvic pain and fatigue after getting Essure.  Last year, at age 29, she had a hysterectomy.

"What they found is scar tissue on the outside of my tubes.  It was actually adhering my tubes to my ovaries to my abdominal wall which was causing all of my pain," said Esther.

She blames Essure.  Farmer thinks the device was responsible for her heart palpatations and cataplexy, episodes in which she would collapse and be paralyzed for a few minutes.

"One hundred percent Essure.  I had my hysterectomy in 2014.  Three days after removal, I have not fallen down with cataplexy yet and it's been one full year," Farmer said.

Farmer and Esther are among more than 20,000 women who've shared their complaints on a Facebook page called Essure Problems.  Both women will attend a meeting in Washington Thursday of an FDA panel reviewing Essure.  Farmer will testify.

"Take it off the market.  It's got to come off the market," Farmer said.

But the FDA is asking the panel to only discuss possible changes to the label and whether more studies of Essure are needed.

"Even if we get as far as starting new clinical trials and looking at what we've got going, that would be heaven for me because right there, it'll show our problems," said Esther.

Bayer, the maker of Essure, issued the following statement:

We have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its approval by the FDA in 2002.  As the manufacturer of this product, we have a responsibility to share the facts about Essure:

 

Most of the adverse events that have been reported recently about Essure are known and have been in the Essure product label. This has been confirmed by the FDA which found that “[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five-year safety] study did not demonstrate any new safety problems or an increased incidence of problems already known.”1 (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm)

 

Essure has more than a decade of research and development in addition to a decade of real world experience. More than 750,000 devices have been sold worldwide. Essure has been shown to be highly efficacious (99.83% based on a 5-year study) and the safety profile has been documented through clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk….”2

 

More than 600,000 tubal ligation procedures are performed in the United States each year.3 We stand by the benefit-risk profile of Essure as an important option available to women who want permanent contraception.

 

No form of contraception is without risk, should be considered appropriate for every woman or is considered 100 percent effective. It is important that women discuss the risks and benefits of any birth control option with their physicians.

References:

1 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm

2 Benefits and Risks of Sterilization (Obstet Gynecol 2013;121:392–404) February 2013

3 Benefits and Risks of Sterilization (Obstet Gynecol 2013;121:392–404) February 2013