“Patient safety is our highest priority and we sympathize greatly with any woman who has experienced problems with Essure”.
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Thursday’s panel will discuss potential changes to Essure’s label or whether more clinical studies should be conducted on the product, but the panel will not formally vote on any measures.
While some love it, thousands of women say they suffered severe side effects.
The Essure device is inserted through the cervix into a woman’s fallopian tubes where it triggers inflammation and the growth of fibrous tissue, blocking the pathway between sperm and egg. When Lacey Gay used it, she says the only thing it prevented was her from living a full life.
“Advertising it as nonsurgical is not only misleading but unethical and potentially criminally deceptive allowing this to continue compromising the trust and welfare of the USA consumer and must stop immediately”, Novoa said. Some of them discussed minor symptoms, like fatigue, while others addressed more serious issues, like the implant becoming dislodged, heavy bleeding.
The FDA has received over 5,000 complaints from users of Essure. It causes continual pelvic and abdominal pain. In 2014, there were 2,259 such complaints, and 1,363 through June 1 of this year, according to the FDA. She says the device needs to be taken off the market. In 2002, the implant was given green signal by the FDA.
Dr. Patricia Carney, the company’s medical director for Essure, said the company welcomes the discussion.
Representatives for Bayer said that skin tests for nickel allergies do not accurately predict whether a patient will have an allergic reaction to a nickel implant.
The company said that the device was studied with the help of 10000 women before being approved.
Also Bayer officials reported that they have been monitoring social-media reports to search out more reports of reactions to Essure and also that they have forwarded some of the complaints to the FDA.
She has had “a couple” of patients come to her with complaints and one asked for the device to be removed. 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.
“I’ve had no problems”, she said.
“I felt like a shark was on the side of my body and wouldn’t let go”, she said.
Three years ago a similar FDA panel convened to review unforeseen problems with metal-on-metal hip replacements. The authors conclude, “Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the pre-marketing approval evaluation indicated”.
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Gabriella Avina, a study participant at a San Ramon, Calif., trial site, was so enthusiastic about Essure that she became a paid spokeswoman for Conceptus for several years, answering questions women wrote in to “Ask Gaby”. “This negatively impacted my marriage and I could not be the mother my children deserved”.
