As reported in the Wall Street Journal, Bayer’s sterility device for women, Essure, has been recommended to undergo additional clinical trials as advised by an independent medical advisory panel. Essure is small metal device that is implanted in the Fallopian tubes. Over time scar tissue forms around it, blocking sperm from reaching the ovaries. The FDA approved its use in 2002.
Incapacitating Pain and Other Complaints
Women complained during clinical trials of pain so severe they were unable to function. These women were then removed from the study. During the last 13 years of Essure use, the company continued to receive an alarming number of complaints from Essure patients suffering debilitating pain.
The panel examined Essure to determine whether more trials were needed and if the labeling and warnings should
be changed. Dr. Diana Zuckerman, president of the National Center for Health Research, reported that over 1000 women were experiencing severe symptoms and that 86% of them were suffering from pain. The symptoms include:
- Persistent pelvic and abdominal pain
- Hair loss
- Disorders that indicated autoimmune disease
Allergic reactions to the device, which is made of nickel and polyester, were indicated by hives or rash, swelling and pain, with nausea. In the 63 patients presenting with allergies, the occurrence of arthritis and asthma was increased.
Product Liability Claims Increase
Dr. Zuckerman found that time and again women who reported these and other adverse side effects were removed from the study, skewing the trial results. She found that many of these complaints weren’t recorded. Essure complaints soared from 115 reported in 2011 to twenty times that amount in 2014 with 2, 259 Essure complaints. Essure complaints filed for the first half of 2015 number 1,363, indicating the problem is still growing.
Bayer’s sterility device, Essure, has caused some outrageous behavior that can be described at the very least as unethical. Bayer denies allegations of misconduct among its doctors during the clinical trials. It has been stated that “Bayer and the FDA have trouble seeing the causal relationship between this device and the patients’ pain,” unfortunately this is not the case for those who have suffered. One Essure user had to endure 20 office visits presenting the same complaint of severe abdominal pain before the Bayer’s sterility device was finally removed.
The panel heard from a number of women about the painful side effects they experienced after having Essure implanted. Some feel that since reporting Essure patient complaints of abdominal pain and pelvic pain to the FDA is optional, there is no clear method to gauge exactly how many Bayer’s sterility devices are causing painful side effects, and to what extent Bayer will be responsible for product liability.
Representation For Your Essure Complaint
If you, or someone you know, has experienced painful side effects after having Essure implanted, securing the best legal representation with knowledgeable lawyers in product liability claims is highly encouraged. Testimony before the independent medical advisory panel shows that Bayer may have acted negligently showing recklessness in its rush to get the FDA approval.
If you have experienced any of the symptoms discussed in this article, or others, you may have a product liability claim against Essure.