Despite FDA approval of the Essure contraceptive implant in 2002, complaints of the device
causing severe side effects have continued to mount. These side effects include, but are not
limited to painful menstruation, vaginal bleeding, perforated fallopian tubes, device rejection
and extreme pain during intercourse. A study out of Northwestern University may have found
supporting evidence that shows flawed data led to the approval of the medical device Essure.
This claim is the result of a team’s analysis on many high-risk medical implant devices.
The team identified 18 high-risk devices approved by the FDA from 2000 to 2015, most of them
for reducing menstrual flow, contraception and fetal monitoring. What they learned was
shocking. Four of the devices, or 22%, were approved even though they failed to demonstrate
efficacy in clinical trials. Six of the devices, or 33%, were not required to undergo post-market
studies to survey ongoing safety. Three devices were eventually withdrawn from the market
after approval. Of those three, two were not reviewed by physician experts on the FDA’s
obstetrics and gynecology advisory committee. The other was reviewed, but not recommended
for approval by the committee.
With all of these flaws, how did these devices receive market approval? The relevance and
extent of the data provided to the FDA for approval may have been skewed in favor of
approving the devices. This was probably the case for Essure. The device, meant to last a
lifetime, was approved based on short-term evidence and insufficient post-market follow-up.
Authors of the study from Northwestern University believe that clinicians in all specialties that
use medical devices have a responsibility to understand how FDA regulation works. Much like
Ariel Grace’s Law hopes to accomplish, this study encourages doctors to take a more active role
collecting and reporting data regarding complications and unintended outcomes from these
kind of devices.
While fighting Bayer in the courts on behalf of over 1000 women, we have continued to
uncover more and more alarming data about Essure, Essure Problems, and how Essure
Problems are being reported by Bayer to the FDA. If you or someone you know has been
injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby +
Williams or call 844-ESSURE- LAW today.
Unglesby + Williams is at the forefront of Essure Litigation, and we will fight for you to get the
compensation you deserve.
