Essure is a permanent birth control system that uses the body’s natural production of scar tissue to prevent pregnancy. The procedure involves the implantation of a small metal coil into both fallopian tubes. Over the course of several months, the body produces scar tissue in response to the implant’s presence, ultimately forming a barrier that prevents sperm from reaching and fertilizing an egg.
From its introduction in 2002 through 2015, the FDA received 9,900 reports from doctors and women that the device caused serious side effects, including serious and continuing pain, organ perforation, allergic reactions, device migration, and death. In response to the numerous complaints, the FDA announced in February 2016 that it would require Bayer to conduct a clinical study on the safety and efficacy of Essure.
In October 2016, the FDA required Bayer to add a black box warning to Essure labelling. Black box warnings are the FDA’s highest level and indicate that a product may cause death or serious injury. It also required that patients and doctors complete a “discussion checklist” in which the patient is fully informed about the dangers of the Essure procedure. Moreover, new labeling was put on the device’s packaging informing doctors of the restriction in use.
Ultimately, the following injuries have been claimed in legal proceedings brought against Essure’s manufacturer:
- Device migration;
- Device fracture;
- Organ perforation;
- Complications requiring surgery;
- A child born with birth defects.
Although Essure litigation is still in its early stages, the number of claimants is growing. Moreover, activists are gaining attention and support, with a large number of advocates encouraging every woman affected by Essure to file an FDA report. So much so that advocates have obtained support of US Congressman Mike Fitzpatrick, who presented a bill to Congress requesting the withdrawal of Essure from the market.
If you of a loved one has experienced any of the complications described herein, or any other injury you believe is related to Essure, contact the experienced attorneys at Neumann Law Group for a free consultation.