Essure Black Box Warning
Written by Faith Anderson on March 2, 2016
FDA Requires New Black Box Warning on Essure Contraceptive Label
After more than 5,000 women have filed adverse event reports with the U.S. Food and Drug Administration (FDA) alleging devastating complications from Essure, the FDA is finally requiring a new “black box” warning for the permanent contraceptive device to “call attention to serious or life-threatening risks.” Unfortunately, the FDA is allowing the potentially dangerous device to remain on the market. If you believe you have been adversely affected by alleged side effects of Essure, like chronic pain, bleeding, device migration, or perforation of the uterus or fallopian tubes, contact a knowledgeable Essure injury lawyer today for legal help. You may be entitled to compensation for your injuries and medical bills, which you can pursue by filing a product liability lawsuit against Essure maker Bayer Healthcare.
Pain and Other Problems from Essure Birth Control
In a press release issued on February 29, the FDA announced “actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.” The potential for Essure to cause devastating side effects first came to the attention of the general public in 2013, when thousands of women began to come forward with tales of “excruciating” pain and serious medical problems they experienced after being implanted with Essure. Despite these adverse event reports, Bayer continues to market Essure as a cheaper, safer and more convenient option for women who want permanent pregnancy protection.
Since 2002, the FDA has continued to monitor the safety and effectiveness of Essure birth control by reviewing medical literature, medical device reports, post-approval study data and clinical trial information, and its latest actions are intended to “help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain woman are at heightened risk of complications.”
Potential Side Effects of Essure Sterilization
Essure is a permanent form of birth control that is implanted directly into the fallopian tubes, where the device’s polyethylene fibers cause a build-up of scar tissue that obstructs the tubes and permanently protects against pregnancy. Approved by the FDA in 2002, following a fast-track review, Essure has been marketed by Bayer Healthcare for years as a safe and effective form of permanent sterilization that doesn’t require surgery. However, thousands of women have reported serious problems allegedly caused by their Essure implants over the years, including side effects like:
- Perforation of the fallopian tubes or uterus
- Migration of the device to other parts of the body
- Unintended pregnancy
- Allergic reaction to the nickel used in the implant
- Requiring a hysterectomy to remove the device
- Wrongful death
Along with unintended pregnancy is the risk of miscarriages and stillbirths allegedly associated with Essure birth control, and just last week, the FDA was provided with raw data showing a total of 303 fetal deaths affecting women who used the permanent sterilization device.
In its February 29 announcement, the FDA acknowledges that, while Essure remains an appropriate option for some women seeking permanent birth control, many women using Essure may face an unexpected risk of devastating complications, including “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.” In addition to requiring a new black box warning on the Essure label, the FDA also issued a mandatory clinical study for the birth control device, to help identify the potential risk of side effects for certain women. The FDA is also requiring that Essure prescriptions include a Patient Decision Checklist to ensure that women receiving the implant are aware of and understand the benefits and risks of the sterilization device.
FDA Keeps Essure on the Market
The FDA’s announcement comes after a lengthy Essure safety review conducted by the agency, in response to thousands of adverse event reports submitted by women who used Essure and have suffered devastating complications as a result. In many cases, women experiencing alleged Essure side effects have required a total hysterectomy to remove the implant after it migrated out of its original position. While some critics expected the FDA to issue an Essure recall, arguing that the potential risks of the permanent sterilization implant outweigh any of its possible benefits, the agency has decided to allow the device to remain on the market, with the strongest label warning the FDA can impose on a product.
The FDA “Truly Failed These Women”
This new black box warning on the Essure label is likely to prompt more Essure side effect complaints, as more and more women across the country become aware of the potential for the birth control implant to cause devastating complications in users, and will likely serve as an important argument for women who experienced severe pain, bleeding, unintended pregnancies, stillbirths and miscarriages while using Essure. Overall, reaction to the FDA’s decision to keep Essure on the market was swift and enraged, with one former FDA contractor stating, “I feel as if the FDA truly failed these women. How can we trust the FDA to make good decisions regarding safe and effective devices?”