FDA to Review Essure Contraceptive Device Amid Complaints

The FDA panel agreed that clinical trials had been troubled, because they were not random and did not include a control group. In addition to establishing a patients registry to elicit more information about possible complications from the use of Essure, some committee members also urged the FDA to require that a formal study be conducted. The panel will not be asked to formally vote on its recommendations until a later date. So far, about 20,000 complaints have been filed by women with a dramatic increase in the number of complaints seen mainly in past two years, said the FDA.

During the Essure procedure, two metal coils are inserted inside a woman’s fallopian tubes and scar tissue forms to block conception.

“I’ve probably done well over 1,000 patients by now”, said Peter Rothschild, a gynecologist from Virginia. Others described debilitating fatigue and the onset of symptoms suggestive of a systemic immune system response to the device.

Minnesota women are among thousands nationwide who say they they’ve suffered serious complications because of a popular birth control device.

USA wellbeing specialists will audit the potential dangers of Bayer AG’s lasting prophylactic gadget, Essure, on Thursday in light of developing grumblings over conceivable reactions, and consider whether its utilization ought to be confined.

For instance, Tish Scott, 34, of Drakesville, Ohio, had the Essure device implanted after having three children.

In its review, the FDA paints a mixed picture of the literature on Essure’s safety.

The group pressed the FDA to investigate the device, which initially appeared at least as safe and effective as tubal ligation, the other method by which women can become sterilized.

Bayer’s medical director for Essure, Patricia Carney, said the company is open to hearing the discussion about the product’s side effects. The product was originally developed by Conceptus Inc., which the German company acquired in 2013.

Bayer said that only a few of lawsuits involving Essure have been there. Bayer says that about 750,000 devices have been sold, majority in the U.S.

At Thursday’s hearing, many women spoke about acute pain and other symptoms.

The safety and efficacy of Essure is supported by more than a decade of research and development and real world clinical experience. She continues, “We, too, are seeing these [adverse] events, but the benefits outweigh the risks”. “Bayer and the FDA have trouble seeing the causal relationship between this device and the patients’ pain”, she told the panel.

Crystal Johnson Brown, now 39, said investigators told her the pain came from pelvic inflammatory disease, an infection of the female reproductive organs, and since it was a sexually transmitted disease, she should seek treatment elsewhere. The product has been available for 13 years, but the FDA has been receiving complaints about the associated side effects since 2013.

“It’s a lot to keep up with your single parent and I felt guilty because I couldn’t do things with my kids”, Gay said.