FDA asks advisers to weigh benefits vs risks of Bayer’s Essure

US regulators said they would review a popular birth control implant device at a panel this week following multiple complaints.

Numerous women who testified against Essure asked the FDA panel to consider whether it’s worth sacrificing their health so severely to provide birth control for other women when there are other options available. It’s a tiny coil that is implanted in the fallopian tubes, scar tissue forms around the coil blocking the tubes and preventing pregnancy.

But thousands of women have attributed other problems to the implant, including some not listed on the warning label: chronic pain, fatigue, weight gain and depression. Critics, in turn, say the FDA has been lax in responding to complaints by patients and in holding the manufacturer accountable for failure to report complaints as required, according to an ABC News affiliate in Arizona. An FDA search of social media uncovered more than 20,000 mentions of problems with Essure, mostly from Twitter.

Standing complaints against Essure already made physicians question its efficacy and safety for recommendation to their patients.

The FDA asked the panel to discuss whether the device should be restricted in some patient groups, or whether changes should be made to the product’s label.

“I have gum disease now and my teeth are starting to rot from the bottom”, Gay said.

Ms. Hudak, of Lakewood, Ohio, said that within weeks of the implant, “I was in almost constant pain”, but said her doctor and nurse in the clinical trial told her this had nothing to do with Essure.

Thursday he FDA will hear from some of those women and make some decisions about the future of this birth control device. Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients. But such negative events are uncommon, said the representatives, who stressed that for most women Essure is safe and highly effective.

The women who talked to CBS4 would ultimately like to see the device taken off the market.

Bayer continued to stand by the device, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied”.

“Now they’re gone and I feel like a totally different woman”, said Gay.

The device is indicated only for women seeking permanent birth control or sterilization.

After 5 years, the first two studies found that none of the women reliant on Essure became pregnant. It says around 750,000 units have been sold, for the most part in the United States. We have also read the stories from women who are sharing their personal experiences with Essure.

“Some short-term pain” is expected with Essure, said a Bayer presenter, Dr. Edio Zampaglione, vice president of U.S. Medical Affairs/Women’s Health at Bayer. Their symptoms aren’t to be taken lightly, they say. “Studies conducted to date may have provided an incomplete picture of Essure”, Dr. Sanket Dhruva, a clinical scholar at Yale University said prior to the event.