Study Warns Essure Approval Based on Flawed Data

June 8, 2016 — After thousands of women were injured by the permanent sterilization device Essure, a new study has found that the FDA approved the high-risk implant with only minimal safety data.

The study was published by researchers at Northwestern University in Obstetrics and Gynecology.

Essure was included on a list of 18 high-risk medical devices that were approved from 2000-2015 with no evidence of long-term safety and insufficient post-market follow-up data.

Four devices (22%) failed to show effectiveness in clinical trials, three were withdrawn from the market, and two were never reviewed by safety experts at the FDA.

Essure was approved in 2002 based on a clinical trial in which data on 11% of participants was lost. Furthermore, researchers followed up with only 25% (197 women) of patients after two years.

Without any long-term safety information, the FDA approved Essure — a permanent implant — with “Pre-Market Approval,” which gives the manufacturer immunity from lawsuits.

After Erin Brokovich took up the cause, a few lawsuits were filed to challenge the immunity. Over 5,000 women have reported severe injuries, and many of them could file lawsuits in the future.

Lawmakers have recently proposed strengthening the FDA’s medical device review process. One of the authors of the study, Dr. Steve Xu, said:

“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?”

In February, the FDA ordered Bayer to conduct new clinical trials and add a “Black Box” warning label to Essure. Last year, a study published by the British Medical Journal found that women who got Essure were 10X more likely to need follow-up surgery than women who had traditional “tube tying” sterilization.