Congresswoman Calls for FDA Action on Bayer’s Essure Implantation

The drumbeat for the removal of Bayer’s controversial implantable contraceptive device Essure is growing louder, with a federal lawmaker becoming the latest to urge the FDA to take it off the market until a well-designed study can demonstrate its safety and effectiveness.

In a letter dated Oct. 9 and addressed to Acting FDA Commissioner Stephen Ostroff, Rep. Rosa DeLauro (D-Conn.), says she is deeply disturbed by health problems experienced by women as a result of Essure implantation, adding that more than 5,000 adverse event reports had been filed. Essure is marketed by Bayer Healthcare, which acquired the implant with its 2013 buyout of Conceptus.

“A citizen petition filed on behalf of hundreds of women injured by Essure asks the FDA to remove the device from the market,” DeLauro writes. “FDA should take immediate action to do so.”

Patient Registry

Her letter also touches on September’s meeting of the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, held to discuss the risks and benefits of Essure. While no official vote was taken on whether the benefits outweigh the risks, the panel recommended the development of a patient registry to monitor outcomes with the implant.

Many women shared their tales of severe adverse events, including bleeding, autoimmune diseases, painful sexual intercourse, unplanned pregnancies, weight gain, tooth and hair loss and excruciating pelvic and abdominal pain. DeLauro took exception with the amount of time — three minutes — each woman was allowed to speak. They also were forced to speak from the audience, rather than speak at a lectern, as FDA officials and Bayer representatives did.

Even expert obstetrician Aileen Gariepy of Yale University was not allowed to speak from the lectern, she writes. Gariepy was among those questioning the data backing Essure and traveled at her own expense.

During her presentation, she said 85 percent of women who got the Essure implant were sterile three months after the procedure. Many women might consider other options with that sterilization rate.

Postapproval Studies

In addition, the panel was not given a chance to hear from women involved in a clinical trial where the sponsor allegedly changed data on patients’ ages and complications, according to DeLauro. She cites three postapproval studies whose data do not include the full breadth of adverse events. Patients allegedly complained that their symptoms, including severe chronic pain, were not accurately documented. At least one woman attested to having her answers to questionnaires changed in her study records.

“Given this background, it appears that Conceptus … systematically grossly underreported symptoms experienced by patients treated with this device,” DeLauro alleges.

In addition to questions about the time allotted patients and failure to invite women involved in the clinical trial, DeLauro also asks whether the FDA has followed up with Bayer on pain and other severe side effects in postmarket trials.

She also asked if the agency tried to obtain long-form study records to help determine how widespread underreporting, crossed-out answers and other data quality issues were in Essure clinical studies.

She also asks why the FDA has posted only 11 of the more than 3,000 comments submitted to a docket of a citizen’s petition urging the market removal of the device, as well as whether it has an estimate of when it might act on the petition.

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