The U.S. Food and Drug Administration (FDA) announced Monday it has approved labeling changes for the controversial Essure permanent birth control system to include a boxed warning about the risk of persistent pain, allergic reactions, uterine perforation, and more.
Essure, which is touted as a nonsurgical permanent birth control method, has received thousands of complaints over the years from women who claimed they were injured by the device. This prompted the FDA to hold a meeting with a panel of obstetricians and gynecologists in September 2015 to address the allegations.
Providing Proper Warning
After reviewing more than 2,800 cases and listening to expert opinions, the FDA concluded that some women were not getting and understanding information about the risks related to the permanent birth control devices.
In February, the FDA recommended the inclusion of a boxed warning with the device. It finalized the guidelines on October 31.
“Among other changes, Bayer, the company that makes Essure, will include a boxed warning and patient decision checklist in the labeling to help ensure that women receive and understand the benefits and risks of these permanent birth control devices,” the FDA wrote on its site.
The black-box warning—the most severe warning issued by the FDA—will warn patients of adverse effects and the possibility of surgery if the device needs to be removed.
The patient checklist also contains key items and risks related to the device. It must be signed by the patient and physician.
Bayer will make the updated Essure label available within 30 days. The official wording of the new label will be released on the Bayer website at that time.
Critics Argue Essure FDA Recommendations Not Enough
Despite the inclusions of these warnings, critics and victims of Essure say it is not enough.
Congressman Mike Fitzpatrick, a long-time critic of Essure, issued a statement saying that the warning is not effective.
“The latest recommendations from the FDA do not go far enough. A boxed warning and patient checklist highlight the severe risks of Essure—but they’re not legally enforceable requirements,” Fitzpatrick said. “Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths.”
Rep. Fitzpatrick is an ally of the grassroots group called Essure Problems and has called for more accountability against Bayer. The group also expressed disappointment at the FDA’s guidelines.
“Today the FDA released their final guidance on Essure,” wrote Angie Firmalino in a statement. “The guidance includes a ‘suggested’ black box warning along with a patient decision checklist. Once again, we find that the FDA has done a pitifully insufficient job.”
The group announced it is officially done trying to work with the FDA.
While some called for the complete removal of Essure from the market, others in the medical community continued to support its use and opposed the updated guidelines. The Association of Reproductive Health Professionals (ARHP) and the American College of Obstetricians and Gynecologists (ACOG) are two such groups.
“ACOG strongly recommends that the proposed black box warning language for hysteroscopic sterilization devices be revised to reflect only supported clinical data, or eliminated from the labeling requirements,” the group told the Regulatory Affairs Professionals Society.
Essure Lawsuits Continue in Courts
Bayer has also run into legal troubles with Essure.
More than a thousand lawsuits have been filed against Bayer for complications that arose after using the devices.
Women bringing the lawsuits against the pharmaceutical giant have seen a few victories earlier this year. In April, a federal judge allowed cases to proceed against Bayer under failure to warn and negligent behavior.
In August, California Judge Winifred Y. Smith also allowed cases to proceed, despite attempts by Bayer to get the cases dismissed.
“I am extremely encouraged by Judge Smith’s decision” said plaintiff lawyer Fidelma Fitzpatrick after the decision. “Women who believe their injuries were caused by Essure deserve their day in court, and we have vigorously argued on their behalf for the right to pursue personal injury claims against Bayer.”
Other Essure lawsuits in Illinois and Pennsylvania are moving forward against Bayer.