September 22, 2015 — The FDA will meet later this week to discuss the safety of Bayer’s Essure sterilization device, which has been linked to over 5,000 adverse events.
The FDA’s Obstetrics and Gynecology advisory panel released a 90-page report (PDF) on Essure ahead of their meeting on September 24.
According to MassDevice, statistics released by the FDA indicate a 1,400% spike in complaints about Essure in the last three years.
One victim, Melanie Goshgarian, 37, told ABC News:
“I felt like a shark was on the side of my body and wouldn’t let go. My whole body started to change. … I was itchy, my arms were tingling and my legs were tingling. … I was confused all the time.”
When the FDA approved Essure in 2002, they granted it fast-track status because it was the only non-surgical sterilization device on the market. Critics say it was never adequately tested, and studies were “replete with fraud.”
The manufacturer is also accused of failing to warn about potential risks. Bayer insists serious side effects are rare, but thousands of women say they now suffer from chronic pain, heavy bleeding, fatigue, hair loss, depression, and other debilitating side effects.
Bayer is now facing a federal lawsuit in California on behalf of Tanya De La Paz, a woman who says Essure caused severe bleeding and chronic pain. The problem is that lawsuits are preempted under a federal law — an injustice, according to Erin Brokovich and other advocates.