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One out of every 10 attempts to remove Essure birth implants may result in complications, according to adverse event reports and post-marketing data released by federal regulators.
On Tuesday, the FDA updated its Essure Information page with an interim analysis of an ongoing post-marketing study by Bayer. The agency also posted a new spreadsheet of adverse event reports and Essure problems experienced by women nationwide.
While the data is still evolving, the interim results seem to confirm a number of serious problems with the Bayer birth control device, which is no longer available 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, the device was removed from the market amid thousands of Essure lawsuits filed by women who experieced painful and debilitating complications, including migration injuries, perforations, severe reactions and other problems.
Although Essure was recalled 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.
Following the decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.
According to the new data, the vast majority of adverse event reports about Essure involve the patient having it removed. This could be because of pain, hypersensitivity reactions or simply because the patient wishes to reverse the sterilizing effect. However, the new data indicates that 10% of those device removals result in complications, including
- Device breakage
- Coil migration
- Fragments remaining in the patient
- Post-operative bleeding
- Uterine or fallopian tube perforation.
The FDA cautions that much of the data has been gleaned from social media and litigation, so it cannot guarantee some of that data is not duplicated.
Essure Settlement Moving Forward
Last month Bayer officials indicated the company is willing to pay $1.6 billion to resolve most of the nearly 39,000 Essure lawsuits.
The agreement includes a fund designed to address outstanding claims, and the manufacturer is continuing to negotiate resolutions for the remaining cases. The company suggested plans to settle Essure cases in its second quarter financial statement.
Plaintiffs who accept the settlement agreement will have to drop their pending claims, and Bayer indicates it will not admit to wrongdoing or liability. However, terms of the agreement, beyond the $1.6 billion figure, are being held confidential.
The company faced a number of approaching trial dates in the litigation, coming as a series of reports were released that highlighted the problems with Essure, including interim results from a post-marketing study the FDA released last month, 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.
Approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures occurring in the United States.