FDA Commissioner Reviewing Safety of Essure
The FDA commissioner, Scott Gottlieb, M.D. released a statement about the permanent birth control solution, Essure. Currently, the agency is reviewing 12,000 new medical device reports and examining the safety of the device.
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer, the manufacturer of Essure, claims it is nearly 100 percent effective at preventing pregnancy and is perfecting safe; however, thousands of women disagree.
FDA Commissioner Essure Report
Since its approval in 2002, the FDA has received thousands of reports of adverse events associated with the device. Then, in November 2016, the agency added a black boxed warning to Essure. The label warned about the risk of implant perforation, device migration, allergic reaction, pain, and other possible adverse events. After adding the new warnings, the FDA asked Bayer to perform a post-market survey. Bayer has not completed it yet. However, the 12,000 medical device reports under review come from plaintiff attorneys releasing data to the FDA. The commissioner did not go into specifics of all their findings, however, he did mention that more than 90% of the reports mention issues involving potential device removal.
“In short, we’re actively working to gain more information on these new reports and to better understand reasons for the device removal. The FDA will be following up on many of these individual reports to gather this additional information,” Dr. Gottlieb writes.
He says the FDA continues to believe that Essure “may be appropriate for some women” based on current information, but the agency also recognizes that “serious problems” have been associated with Essure.
Essure Banned Everywhere Else
This statement from the FDA commissioner could be under pressure since Bayer has stopped selling Essure in all other countries except for the United States. Bayer’s decision comes after Brazil, Canada, Australia, and the European Union refused to have Essure still sold in their countries. Bayer claims they haven’t made a profit, hence why they pulled the device. However, the company also isn’t making a huge profit here either. In 2016, Bayer lost over $400M due to injuries caused by the device. Almost 10,000 women filed complaints with the FDA due to horrific side effects they experienced when using the device. This led to thousands of lawsuits against the manufacturer.
We Want to Help Essure Victims
It is your right for manufacturers to inform you about the long-term risks associated with the medical devices. Additionally, it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Essure, you should demand accountability from Bayer. Why did no one tell you? Of course, we want to help send a message that this is not acceptable. We are advocates for consumers harmed by dangerous products. Likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal. As well as for your physical and emotional suffering. There is no obligation.