March 4, 2016
Thousands of women have looked to the hysteroscopic sterilization product Essure® as a safe and effective method of permanent birth control. However, since the device was approved by the FDA in 2002 over 5,000 reports by women and their doctors show it to often have serious and life-threatening side effects. These adverse events have led several women to file lawsuits against the device's manufacturer, Bayer, and more recently the Food and Drug Administration has also taken action by demanding further investigation into these claims.
What is the Essure® Permanent Birth Control Device?
Essure® is a permanent birth control method the involves the insertion of flexible soft metal coils wound with synthetic fibers through the cervix and vagina into the fallopian tubes. Sperm is prevented from reaching the eggs through the blockage created by scar tissues that form around and adhered to the coils. This process usually occurs over the course of about a three month span and while waiting for the scar tissue to fully form around the fibers, women are asked to use an alternative form of contraception.
Side Effects Associated with Essure®
Over the last 14 years, women and their doctors have reported Essure® side effects that include:
- Severe allergic and hypersensitity reactions
- Extreme fatigue, depression and weight gain
- Incorrect compatibility, positioning or migration of the device including "expulsion" and device breakage
- Chronic pain in the pelvic region
- Life-threatening ectopic pregnancy
The FDA Takes Further Action Against Bayer and Essure®
Since gaining approval in 2002 the FDA has received over 5,093 reports from doctors and women regarding the adverse effects of the hysteroscopic sterilization procedure. These complaints range from minor complications such as allergic reactions, headaches and fatigue to to much more serious conditions such as life-threatening ectopic pregnancy and death.
As a result, the Food and Drug Administration held a special Advisory Committee meeting to discuss the safety and effectiveness of Essure® in September of 2015. The Obstetrics and Gynecology Devices Panel of Medical Devices Advisory Committee convened to review and discuss the available scientific data pertaining to Essure®, hear the concerns of women who have gone through the implant procedure and gain the opinion of other experts from the scientific and medical community. The panel also discussed recommendations for better data collection to understand the adverse events associated with the procedure, improved training and education for clinical professionals. Patient counseling to facilitate informed decision makings and labeling modification recommendations were also discussed.
More recently, on February 29th, 2016 the U.S. Food and Drug Administration issued a press release outlining the additional actions taken against Essure® to better inform its users of potential complications of the sterilization procedure. Most notably, the FDA issue a mandatory clinical study "to determine the heightened risks for particular women" and require new product labeling for the product explaining the averse effects associated with it's use, insertion and removal.
"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."
As part of the draft guidance issued but he FDA, Bayer, the company that manufactures Essure® must conduct a "postmarked surveillance study designed to provide important information about the risks of the device in a real-world environment." Specifically, the study will focus on better understanding the risks associated with Essure® as compared to alternative methods of tubal ligation, such as laparoscopic ligation and how the variety of negative side effects associated with the device affect the lives of patients who have used Essure®. The study will also attempt to understand why some patients have not received follow-up appointments within three months to make sure the device was placed properly. The FDA will look to use the results of this study to determine a further course of action necessary to protect public health.
Read the full press release here.
If you or a loved one underwent the Essure® permanent birth control procedure and are experiencing any of the associated side effects listed above, our experienced medical malpractice attorneys are available to discuss with you all available options and remedies.
Please contact us by using the contact form found on this page or by calling us at (858) 481-5454.