Essure’s Failure Depicts Flaws In FDA Approval Process
12/11/2015 - The epic failure of the Essure sterilization is a perfect illustration of the problems associated with the FDA’s medical device approval process and continued recalcitrance in failing to revoke the premarket approval granted to the device. More specifically, the process reveals the error in how medical device companies test products on patients after the products have been approved and marketed. Standards for premarket clinical trials are shocking low, particularly for medical devices. While many drugs undergo two randomized, double-blind trials, medical devices more commonly undergo one clinical trial, which doesn’t have to be randomized or double-blind.
Even more concerning is the fact that most of the clinical trials are either conducted by the manufacturer or a third-party company contracted by the device manufacturer, which aren’t exactly impartial researchers. When the FDA approved Essure in November 2002, the pre-market studies only reported data from 89 percent of the participants. Were participants with negative side effects, “lost in follow-up?” Additionally, only 25% (a mere 197 women) were followed after two years to see how the device was working. Furthermore, despite the FDA requiring Conceptus to provide follow-up data on patients after five years, only one study was published seven years after completion.
The lack of premarket clinical trial data and follow-up is especially concerning because after a device is marketed to the public, it can malfunction for years before the FDA realizes it and even longer for the FDA to affirmatively address it. The Essure failure exemplifies this perfectly. For several years, women harmed by Essure have been vigorously lobbying for the FDA to take action regarding the defective device. After years of pressure, the FDA finally held a hearing on September 24, 2015 to allegedly address concerns regarding the safety of the device. The FDA announced it would reach some decisions regarding the product by the end of February 2016. Meanwhile, women are undergoing surgery every day to have the product removed, while other unsuspecting women continue to be implanted with the defective device.
While medical device development is certainly beneficial, patients would be better served if the devices were tested more slowly with greater caution, particularly non life-saving devices such as the Essure birth control device. The number of medical devices recalled has doubled in the last ten years, but the approval process has become easier and more rapid. The medical device manufacturers are a powerful group, which spend millions lobbying Congress for favorable legislation such as the 21st Century Cures initiative. Although promoted as legislation, which would, “speed the process from scientific discovery to health treatments and cures for people who need them,” the Act basically allows companies to simply submit evidence of safety and efficacy based on anecdotal data rather than actual clinical trials. High-risk devices will be able to be marketed without going through rigorous scientific testing. This is unacceptable. Medical devices need more testing, not less.
It is hoped that lessons will be learned from the devastation that Essure has caused to thousands of women. Congress is considering a Bill, introduced by Representative Mike Fitzpatrick, which would require the FDA to revoke the premarket approval granted to the Essure device. Women are urged to contact their Representatives and urge support for the E-Free Act. Women who have been harmed by Essure can seek a free confidential consultation from Ennis & Ennis, P.A. by calling or visit us online at www.EnnisLaw.com and fill out an online form.