Birth Control Device Essure Linked To Serious Medical Problems
Essure, manufactured by Bayer AG, is a permanent form of birth control and considered a type of hysteroscopic sterilization. The device is a spring-like mechanism with synthetic fibers inserted into the fallopian tubes to create a barrier. The barrier, consisting of scar-tissue, is developed over the next few months. The barrier is what prevents pregnancy. It is considered a non-hormonal, minimally invasive procedure. However, there have been serious problems linked with Essure.
Some of those issues include migration of the device, accidental pregnancies, chronic pelvic pain, or organ perforation. These are not all the side effects, as there is a range of serious side effects and disabilities associated with Essure.
Since Essure’s approval in 2002, the FDA has continually monitored reports on the product’s safety. From initial approval in November 2002 until January 5, 2018 there have been 26,773 medical reports related to Essure. Between 2016 and 2017, there was increase of 6,835 reports received by the FDA. (In 2016, there were 5,019 total reports. In 2017, there were 11,854 reports.) The most common complaints relate to abdominal pain, heavier menstrual irregularities, nickel allergy, migration of the device, dislodged or dislocated, device breakage, or malposition of the device.
FDA Looks Into Essure Medical Concerns
In 2015, the FDA held a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee specifically regarding the safety concerns of Essure. They covered the following:
- Discussed the current scientific data pertaining to Essure’s safety and effectiveness
- Heard expert opinions on the risks and benefits of the device, and
- Heard concerns and experiences from women who were implanted with Essure
In February 2016, after thousands of reported complaints, the FDA required Bayer to conduct a clinical study on the safety and efficacy of Essure. In September 2016, the FDA approved a post-market study plan by Essure. They believed this data would help understand complications in women who have Essure versus women who undergo tubal litigation. At the end of 2016, the FDA required Bayer to add a Black Box Warning for Essure labeling. In October 2016, the FDA issued final guidance to Bayer and requiring a Black Box Warning for Essure labeling.
Have You Or A Loved One Experienced Medical Problems Using Essure?
The FDA is still accepting reports of adverse events to help better understand the risk associated with Essure. If you have experienced problems with Essure, there is a chance you have a valid claim against the manufacturers of Essure. In order to explore your legal options you need to speak with an experienced lawyer as soon as possible. Please contact us online or call us directly at 318.541.8188 to schedule your free consultation.