Essure Complaints Involving Pain, Bleeding, Organ Perforation and Other Problems Withheld from FDA: Lawsuit

New documents revealed during discovery in the ongoing Essure lawsuits filed over Bayer’s controversial birth control implant suggest the manufacturer failed to submit thousands of adverse event complaints to federal regulators, according to a recent report.

On July 9, the legal public watchdog group, Public Justice, released hundreds of recently unsealed documents linked to the Essure litigation.

The documents suggest Bayer may have hid reports of harmful Essure complaints from the FDA for years, which appear to confirm many women’s claims about problems with the now-defunct birth control device. However, the practice appears to have started with the original creator of the Essure design, Conceptus, which was acquired by Bayer in 2013, suggesting manufacturers were aware of problems for nearly as long as it had been on the market.

Essure was previously sold by Bayer as a permanent form of birth control, involving flexible coils inserted into the Fallopian tubes. It was used during a procedure designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, an Essure recall was issued amid thousands of lawsuits filed by women who outlined painful and debilitating complaints after receiving the coils, including migration injuries, perforations, severe reactions and other problems.

Although Essure was removed from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.

Public Justice noted that Bayer turned over millions of pages of documents as part of the ongoing litigation, but claimed 99% of them were confidential. However, the group filed a motion to unseal many of the records in February, and have received hundreds of documents once kept hidden from the public.

Among some of those records was evidence Bayer failed to report thousands of Essure complaints involving injuries, which critics say made it impossible for federal regulators to provide proper warnings to the public regarding risks associated with the device.

The documents came to light just a day after the FDA issued interim results from ongoing Essure post-marketing studies, which found that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.

Bayer currently faces more than 18,000 product liability lawsuits filed by women nationwide, each involving similar allegations that the Essure birth control coils were unreasonably dangerous and defectively designed. With approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures in the United States, the size and scope of the litigation may continue to increase as Essure causes problems for women with the device in their body.