June 8, 2016 — A new study has found the FDA used flawed data to approve Essure, a controversial sterilization device that has harmed more than 25,000 women.
When the FDA approved Essure in 2002, pre-market studies reported data from only 89% of participants. They may have excluded women with negative side effects. Furthermore, only 25% (197 women) were followed after two years to see how they were doing.
Despite no long-term safety data on Essure — a permanent implant — the FDA gave it “Pre-Market Approval,” which gives the manufacturer immunity from lawsuits. At least five lawsuits are challenging this immunity. If they are successful, thousands of lawsuits may be filed.
The study was published this month in Obstetrics and Gynecology by researchers at Northwestern University. Essure was included in a list of 18 high-risk devices the FDA approved between 2000 and 2015 based on short-term evidence and insufficient post-market follow-up.
Researchers also found that four of the devices (22%) were approved despite failing to show effectiveness in clinical trials. Three devices were withdrawn from the market and two were never reviewed by safety experts at the FDA.
The long-term risks of Essure include extreme pain, migraine headaches, auto-immune reactions, ectopic pregnancy, bleeding, fatigue, depression, weight gain, organ damage, and even death.
Meanwhile, Congressman Mike Fitzpatrick (R-Pa.) is introducing legislation to strengthen the FDA’s medical device review process.
One of the authors of the study, Dr. Steve Xu, told LifeSiteNews:
“There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”