When Pennsylvania Congressman Mike Fitzgerald called on the U.S. Food and Drug Administration (FDA) to conduct a probe into the safety of the contraceptive device Essure allegedly linked to thousands of adverse events, he never expected he’d be opening a figurative can of worms. This week, Rep. Fitzgerald announced that an investigation into Essure uncovered 303 fetal deaths, a far cry from the five the FDA said it had on file.
Essure, made by Bayer Healthcare, was approved by the FDA in 2002 and remains the only non-surgical, permanent birth control method on the market. It consists of two nickel alloy coils that are implanted into the fallopian tubes. The coils build up scar tissue that acts as a natural barrier preventing sperm from reaching the egg.
In recent months, a group of women formed the Facebook group Essure Problems, a site where women could share their experiences with the device. More than 25,000 women now belong to the group. Since the group’s creation, thousands of women have posted complaints including allergic reactions, infections, severe pain, and autoimmune disorders. In some cases, the implants have migrated, perforating the fallopian tubes or uterine wall, or embedding into other organs.
Rep. Fitzpatrick took on the cause and introduced legislation called the E-Free Act. If the bill passes, it would force the FDA to remove Essure from the market. Last September, the FDA launched an investigation into the devices, during which independent researchers found Essure was linked to hundreds more fetal deaths then the agency had reported.
Also this week, Rep. Fitzpatrick announced he had received an unsealed complaint from a federal lawsuit against Bayer alleging the company “provided illegal kickbacks in the form of free medical equipment valued at $20,000.”
The FDA is expected to announce its recommendations regarding Essure later this month.