The Essure Permanent Birth Control System is made up of two metal coils that doctors place inside the fallopian tubes. Thousands of women claim the device injured them, and it should be banned. Essure is manufactured by Conceptus Inc., a subsidiary of Bayer AG.
Essure was designed as an alternative to tubal ligation, the standard procedure for surgical sterilization. Tubal ligation is major surgery that is done in a hospital and requires anesthesia. Essure can be done in a doctor’s office with less anesthesia. Conceptus Inc. claims the device is nearly 100 percent effective at preventing pregnancy.
Evidence shows that Bayer may have purposefully hidden side effects related to Essure from the FDA and failed to warn patients of the side effects.
Complications from Essure include:
- Abdominal pain
- Heavy periods
- Autoimmune disorders
- Device breakage
- Device displacement
- Weight fluctuations
- Severe pelvic pain
- Allergies to nickel
The FDA held a panel discussion in September 2015 to discuss the safety and efficacy of Essure. It did not recommend banning the device, but it released additional guidelines for its use.
Women have filed lawsuits that allege Conceptus violated the terms of the FDA’s premarket approval and committed fraud by withholding data from the agency. This could mean the company forfeited its protection under the preemption laws.
Can I file a lawsuit if I have have been injured by Essure®?
Possibly. If a manufacturer produces a dangerous or defective product, it can be held responsible to those who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has been harmed by Essure®, you should contact your doctor immediately. You may also wish to contact an experienced Essure® lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.