FDA Recommends Black Box Warning for Permanent Contraceptive Essure
After becoming linked to serious health complications for users, Essure, a form of permanent birth control, now carries a black box warning from the US Food and Drug Administration (FDA), and is being subjected to a mandatory clinical study to investigate whether or not the device carries excessive health risks for certain women. The FDA has also ordered that women who are considering the device be required to complete a Patient Decision Checklist, designed to ensure that they have all available information on the risks involved before moving forward.
Essure, manufactured by Bayer Pharmaceuticals, has been marketed as an alternative to tubal ligation for women who want a permanent form of birth control but do not wish to undergo a surgical procedure. Doctors insert flexible coils in the patient’s fallopian tubes by going through the cervix and vagina. Over the course of 90 days, scar tissue forms around the coils, eventually blocking the path of sperm that might travel up the fallopian tube and preventing egg fertilization. Essure was approved for sale in the US in 2002.
Since its approval, Essure has been linked to serious side effects and failures as a defective medical device, including perforation of the uterus and other organs, allergic reactions, irregular bleeding, migration of the device, long-term pain, and unintended pregnancy. The new black box warning that will now accompany Essure will include warnings about the risks of injury and unintended pregnancy, with the Patient Decision Checklist serving as a means for the doctor to confirm that the patient understands those risks prior to implantation of the device.
The FDA has received over 5,000 reports of patient injury over the ten years the device has been on the market, and reports of the deaths of four patients. Nevertheless, the FDA has taken the relatively lenient measures of allowing the device to remain on the market for years potentially while Bayer conducts additional clinical studies and analyzes patient complaints so far received. One congressional representative, Mike Fitzpatrick of Pennsylvania, has called for the revocation of market approval for Essure, citing data that links the contraceptive to over 300 fetal deaths and tens of thousands of injury reports. Already, dozens of women have filed lawsuits against Bayer for their Essure-related injuries.
If you or someone you love has been injured by Essure or another dangerous medical device in California, contact the compassionate and trial-ready Los Angeles medical malpractice and dangerous medical device attorneys at Magaña Cathcart & McCarthy for a free co