Even after more than 5,000 women have complained about the contraceptive device, Essure, Bayer Pharmaceuticals continues to make and sell this lucrative device. Essure is a permanent contraceptive device that creates a blockage in the fallopian tubes, thus preventing the sperm from reaching the egg.
However, several women have reported device ineffectiveness, as well as serious, life-threatening complications.
For years, the FDA has monitored Bayer, ordered medical investigations, implemented safety warnings, and enforced protection measures in an effort to safeguard potential patients. Women are still not receiving warnings about reported side effects of Essure. These measures by the FDA will hopefully help this failure to warn.
In an effort to further restrict Bayer’s distribution of Essure, the FDA recently ordered Bayer to add a multi-page checklist of potential health risks to the Essure label. Now, however, that checklist of side effects must be distributed to potential users.
Each patient must be allowed the opportunity to read and sign this document of risks before they agree to use the Essure permanent contraceptive. All doctors and health-care facilities that provide Essure will need to give potential patients this document, and the physician who implants the device must sign the form.
The FDA has stated that Bayer will be responsible for upholding these new rules and could face serious criminal and civil penalties if they fail to comply.
To date, thousands of women have dealt with life-altering complications believed to be caused by Essure. Side effects reported by Essure users include chronic pain, heavy bleeding, debilitating fatigue, device migration, depression, headaches, unintended pregnancy, stillbirth, and autoimmune disorders.
(Source: Fibich, Leebron, Copeland & Briggs)