Women who have suffered injuries and complications from the Essure permanent birth control system continue to pursue legal action against the device’s manufacturer, Bayer.
Thousands of women have filed lawsuits alleging a range of injuries. The plaintiffs want to hold the manufacturer responsible for an allegedly harmful device, Top Class Actions reports. Activist Erin Brockovich has joined the women in their legal battle against Bayer.
Critics say Bayer has tried to use Food and Drug Administration (FDA) pre-market approval rules to avoid responsibility for manufacturing the allegedly defective product. But two new pieces of legislation are intended to offer support for women who have been injured by this permanent birth control system.
The Food and Drug Administration (FDA) approved Essure in 2002. Essure consists of two flexible metal coils that are inserted into the woman’s fallopian tubes in a brief procedure in a doctor’s office. The coils create scar tissue that blocks the tubes and prevents pregnancy. Before the woman can stop using other birth control, the fallopian tube blockage must be confirmed by a scan a few months after Essure is inserted.
When Essure first came on the market, many women were excited to have a nonsurgical and noninvasive method of permanent birth control. The insertion procedure is quick and does not involve the pain, risks, and recovery time of surgery. But women have been experiencing Essure complications since the device received FDA approval in November 2002. The complications include: persistent pelvic pain or cramping; infection; device migration; organ perforation; unintended pregnancy; ectopic pregnancy (pregnancy outside the womb); miscarriage; irregular bleeding; and metal allergy. Injured women say Bayer downplayed possible Essure complications while emphasizing Essure’s ease and convenience.
U.S. Representatives Mike Fitzpatrick and Louise Slaughter introduced the first piece of Essure legislation, Ariel Grace’s Law, on June 8, 2016. The bill is named after an unborn child conceived allegedly due to an Essure failure. Ariel Grace died at 27 weeks of gestation, Top Class Actions reports. Before this bill, it was difficult or impossible for most injured women to pursue legal action against medical device manufacturers.
Congressman Fitzpatrick introduced the Medical Device Guardian’s Act of 2016 the same day as Ariel Grace’s Law. This second bill would require doctors to report failures and problems with medical devices they use. The act would protect doctors from personal liability and prosecution when they report device failures. Many hospitals had allegedly discouraged physicians from reporting defective devices in order to avoid prosecution. If the Medical Device Guardian’s Act becomes law, regulators should have an easier time removing dangerous devices from the market.
In 2015, the FDA undertook an investigation of Essure injuries and complications. In September 2015, the FDA’s Obstetrics and Gynecology Devices Panel gathered scientific and clinical information about Essure and listened to women’s accounts of their experiences with Essure. Though many of the injured women have called for Essure to be removed from the market, the FDA did not order Bayer to withdraw Essure. But to address the risks, Essure now carries a black box warning on the label and there is a Patient Decision Checklist to help women understand the risks and benefits of Essure.