Essure is a permanent form of birth control in which a coil is non-surgically inserted into a woman's fallopian tubes. Scar tissue is then to accrue around the device, which prevents sperm from reaching and fertilizing eggs, and thereby preventing pregnancy. This device was approved by the FDA for use in 2002.
However, between 2002 and 2015, more than 5,000 women filed grievances with the FDA about complications caused by Essure. These complaints cover a range of issues, including unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after Essure implantation.
The FDA began an investigation into Essure and the associated complaints. Many groups, including women who suffered side effects as well as lawmakers were calling on the FDA to ban the device. However, many were surprised on February 29th when the FDA stated that it found “While there are risks associated with the use of Essure, there are also benefits” and announced that the device would remain on the market, with the addition of a “black box” label warning which would alert potential users to the potentially serious side effects as well as a checklist for doctors to discuss potential risks with their patients. In addition, the FDA is requiring the manufacturer to conduct additional studies into the safety of the device.
In response to the FDA's announcement, Bayer, the pharmaceutical company responsible for manufacturing and promoting Essure, stated “Patient safety and appropriate use of Essure are our greatest priorities. A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”
Several groups felt the action taken by the FDA was not severe enough. “Essure Problems”, a group representing women who experienced side effects from the device issued a statement warning that “These studies could take several years, and leaving the device on the market will only put more women's lives at risk.” In addition, legislators from both sides of the aisle have spoken out against the FDA decision. Representative Rosa DeLauro (D-CT) stated: “Essure should be off the market until the requested studies are completed.”
While Essure will remain on the market for now, Bayer is still facing many lawsuits from women who claim they suffered serious side effects after using the device. Defective medications and medical devices can cause serious injuries and even result in death. If you suspect that you or a loved one may be the victim of a defective medicine or a defective medical device, you should seek medical attention and the counsel of an experienced medical malpractice lawyer.