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Essure Birth Control Device Receives FDA's Strongest Warning

The U.S. Food and Drug Administration (FDA) recently announced that it will require the Essure birth control implant to carry the strongest safety warning label. The black box warning follows thousands of adverse event reports associated with the use of the medical device.

Essure is touted as a safe alternative to tubal ligation as a means of permanent birth control. However, patients implanted with the device report a range of serious side effects, including perforation of the uterus or fallopian tubes, chronic pain, bleeding, autoimmune disorders, and severe allergic reaction.

As detailed in a recent statement, the FDA intends to require that a boxed warning and Patient Decision Checklist be added to the product labeling. The safety statements set forth in the boxed warning are intended to better communicate to patients and providers the significant side effects or adverse outcomes associated with the Essure device and other permanent hysteroscopically-placed tubal implants. Meanwhile, the Decision Checklist contains key items about the device, its use, and safety and effectiveness outcomes.

The FDA also issued draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization,” to provide the public an opportunity to comment on the proposed language to be included in these warnings. After a 60-day comment period, the agency will make any necessary changes and issue final guidance.

In addition to the new FDA warnings, the agency continues to investigate a number of allegations against the maker of Essure, Bayer AG. They include clinical trial misconduct, notably that clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences, as well as violations of FDA regulations related to the manufacturing and marketing of Essure. The FDA has also ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks.

If you or someone you love has suffered serious harm due to a recalled or otherwise defective medical device, you may be entitled to compensation. To discuss your legal rights, contact a San Diego medical product liability lawyer at the Law Offices of Robert Vaage for a free consultation.