Essure, a contraceptive medical device manufactured by Bayer, is designed as a form of permanent birth control. Unfortunately, many women who have used the contraceptive have reported unexpected side effects and serious complications. After receiving thousands of reports of problems with Essure, the FDA held a recent public meeting of its Obstetrics and Gynecology Devices advisory panel to review scientific data about the safety and effectiveness of Essure. More than 20 women described a host of problems and ailments that they think were caused by adverse effects of the Essure device. Members of the FDA advisory committee said Bayer should provide women with more detailed information about the risks of having Essure implanted.
Essure is implanted in a woman’s reproductive system during an out patient procedure at a medical facility. A physician inserts an Essure flexible, metal spring into each fallopian tube through the cervix, causing scar tissue to gradually form around the coils and block the fallopian tubes to prevent insemination and pregnancy. The blockage of the fallopian tubes through growth of scar tissue takes several months. According to Bayer, more than 750,000 women have had an Essure contraceptive device implanted since the device went on the market in 2002.
Reported Medical Complications with Essure Device
The complications that have been reported in connection with the Essure device include:
- pain during the implantation procedure that persists afterward
- bleeding irregularities
- perforation of the uterus or fallopian tubes by the Essure insert
- movement of the medical device in the abdomen
- metal allergy
From November 2002 when the device was approved until May 31, 2015, the FDA has received more than 5,093 reports of medical problems associated with Essure. The reports included more than 400 cases of the Essure coils dislodging after implantation and moving to other parts of the reproductive system.
The most common reported complaint with Essure, according to the FDA, were more than 3,300 incidents of abdominal pain. The FDA said it had received 1,408 reports of menstrual irregularities, 1,383 involving headaches, 966 reports of fatigue, 936 of weight fluctuation and four reports of patient deaths. The most frequently reported problems with the device include nearly 500 reports of device migration from the fallopian tubes and 259 reports of device breakage.
A recent editorial in the New England Journal of Medicine pointed out shortcomings in the FDA’s pre-marketing and post-marketing assessments of the medical device. Although Essure is designed to remain in place for a woman’s lifetime, the journal noted that few women in the studies were tracked for more than a year, precluding any valid conclusions about the long-term risk of the contraceptive.
The FDA’s approval of the device was conditioned on two post approval five-year follow-up studies on women in the earlier studies. The journal noted that the studies were not made well known, the clinical trials were not registered and the results were not distributed in a timely fashion. It also said the available evidence suggests that Essure is not as safe or as effective as the pre-marketing approval evaluation indicated at the time.
If you have been injured by a defective medical device, you have a legal right to seek compensation for your injuries. It’s important to be represented by a knowledgeable defective medical device attorney. At Hardison & Cochran, we are committed to ethical, but aggressive representation of people who have been injured by medical devices to help you obtain the compensation you deserve. We represent individuals, not corporations. We may be reached by calling (800) 434-8399 or you may contact a medical device lawyer online.