On the heels of new federal labeling recommendations, the US Food & Drug Administration has approved an updated label for Essure, the permanent birth control implant linked to severe, often life-altering, side effects.
New Essure Label “Consistent” With FDA Guidance
In several recent press releases, the FDA has confirmed that Bayer’s new labeling for the medical device is “consistent” with strengthened federal guidelines, initially released on October 31, 2016. While the revised label has yet to be published, officials say the documents will become public by November 15.
Essure, a system involving two metal coils implanted in the fallopian tubes, has been linked to numerous severe side effects in patients. In its own suggested wording for the black box warning, the FDA highlights “persistent pain” and “suspected allergic or hypersensitivity reactions,” along with symptom-related device failures, like perforation of the uterus.
Reporters at Medscape have asked the FDA and Bayer for the newly-approved Essure labeling, but their request was declined. However, an FDA spokesperson told Medscape that the new label’s “black box” warning is “identical to the example in the final FDA guidance,” which reads:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and / or reported adverse events, including perforation of the uterus and / or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
Specific language for the device’s “patient decision checklist” is still unknown.
FDA Investigation Of Essure Citizens’ Petition Closed
With these changes now approved, the FDA says it has finished looking into a citizens’ petition that accused Bayer of falsifying clinical trial records and violating the terms of Essure’s Pre-Market Approval order.
The petition, signed by over 2,100 women who are fighting to have Essure pulled from the market, did not spark the formal FDA investigation that petitioners had hoped. Instead, the petition was classified as a “trade complaint,” and thus forwarded to the Office of Compliance, a division within the agency’s Center for Devices and Radiological Health tasked with enforcing medical device laws.
After reviewing relevant clinical trial records, the Office of Compliance concluded that less than 1% of the case reports related to pain, bleeding and other side effects had been altered during clinical trials. The FDA “did not find evidence [that Bayer had] purposefully modified patient responses to reflect more favorable data for Essure,” the agency announced in a subsequent report.
“Essure Problems” Supports Complete Device Recall
Reports implicating the device as a cause of serious harm, however, are not difficult to find. Tens of thousands of women say their own severe side effects can be directly tied to Essure. The problem has inspired a grassroots movement under the banner of “Essure Problems.” Boasting a membership of nearly 31,400 users, the Essure Problems Facebook page has become a crucial gathering place for women seeking support and information on the device’s potential risks, along with removal strategies.
Their ultimate goal? To see Essure recalled from the market. While most device recalls are initiated by manufacturers, the FDA has the legal authority to compel recalls for products “associated with significant health problems or death.” Thus far, neither Bayer nor the FDA have chosen to recall Essure.
But many of the federal agency’s recent decisions to strengthen the device’s labeling can be traced back to the advocacy of Essure Problems’ members. It was largely Essure Problems that urged women who were experiencing health problems to report their side effects to the FDA. The agency has received nearly 10,000 adverse event reports related to Essure since the implants were first approved in 2002.