FDA Updates Essure’s Warning Label Instead of Recall
This is Amy German, Managing Associate Attorney for The Michael Brady Lynch Firm.
After treating women as though their injuries were invalid, the FDA is finally asking Bayer, the manufacturer of Essure, to update the warning label on the dangerous permanent birth control, Essure. The new label will include warnings for the risk of implant perforation, device migration, allergic reaction, pain and other possible adverse events. The Essure box will now also include a patient checklist. It reviews possible risks such as the metal coil perforating the uterus or fallopian tubes. However, many women feel this is not enough.
This label change is the FDA’s response to a citizens’ petition filed last year. Signed by over 2,000 women, the petition asked the FDA to recall Essure. It alleged that Bayer deceived the public and the FDA about the device’s safety and efficacy by falsifying clinical trial records. The FDA admits that Bayer altered a percentage of patient records; however, the FDA says there is no evidence that Bayer purposefully modified data to make Essure look better.
Bayer along with medical professionals pushed Essure as the best non-surgical option of sterilization. Approved in 2002, Essure is a permanent form of birth control that uses nickel-titanium coils. A doctor inserts them into a woman’s fallopian tubes in the office. Scar tissue is supposed to form around the device to prevent sperm from reaching eggs to fertilize them. Bayer estimates 750,000 women have received the device since 2002. However, over 10,000 women filed grievances with the FDA. They complained of unintended pregnancies, miscarriages, stillbirths, abdomen and pelvis perforation and even death.
If you or someone you know has suffered an adverse event after using Essure, you may be eligible for compensation to ease the financial and emotional burdens you are experiencing. Contact us today to set up a free consultation, during which we will listen to your story, answer any questions you may have and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.