FDA Issues Essure Sales Restriction
The FDA issued an order on April 9, 2018, restricting the sale and distribution of Essure, a permanent birth control solution, after years of receiving complaints about its side effects. Manufactured by Bayer, Essure will now only be sold to health-care facilities that provide full information about the device’s risks and benefits.
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.
About the FDA Essure Sales Restriction
Just last month, the FDA commissioner, Scott Gottlieb, M.D. released a statement about reviewing nearly 12,000 medical reports from 2017 and examining the safety of the device. The FDA said Bayer did not properly inform medical professionals of the risks of Essure before implantation. If facilities do not comply, Bayer could face civil or criminal penalties.
Essure Banned Everywhere Else
This statement from the FDA 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 even though 70% of sales come from the United States. Also, 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.
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 injured consumers. 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.