The U.S. Food and Drug Administration (FDA) used faulty data to approve the Essure contraceptive and other high-risk medical devices, according to a new study.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after receiving a contraceptive implant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
June 6, 2016 – The study, which was published this month in the journal Obstetrics and Gynecology, listed the Essure “permanent contraceptive device” among 18 medical devices posing the greatest risk to patients that were approved by the FDA from 2000 to 2015. Essure received approval based on short-term evidence and insufficient post-market follow-up, according to the study.
“Recent controversies surrounding obstetrics and gynecology devices highlight the need for deeper understanding of obstetrics and gynecology medical device regulation,” the researchers said. “Our results reveal significant weaknesses in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices.”
Approved in 2002, Essure is metal coil which is inserted into a woman’s fallopian tubes to create scar tissue and block eggs from being released into the womb for fertilization. Unfortunately, the device has been linked to thousands of reports of adverse health complications. Serious side effects of Essure may include:
- Ectopic pregnancy
- Unintended pregnancy resulting in severe complications and miscarriage
- Pelvic complications
- Migration of the metal inserts through the fallopian tubes into the abdomen
- Puncture of the uterus
- Perforation of the fallopian tubes
- Organ damage
- Weight gain
- Menstrual irregularities
- Severe pelvic pain
The study’s authors say their findings indicate that FDA approvals should be based on more rigorous clinical studies than are currently required, both before and after medical devices enter the market.
In addition to contraceptive devices, the researchers looked at products approved for things such as reducing menstrual flow and fetal monitoring. Of the medical devices reviewed for the study, 6 of them (33%) were not required to undergo post-marketing research to investigate ongoing safety. Four of the devices (22%) were even approved after failing to demonstrate effectiveness in clinical trials.
Three devices were subsequently withdrawn after gaining approval. Of these, 2 weren’t reviewed by FDA’s obstetrics and gynecology advisory committee’s physician experts, and the one that was reviewed failed to get its recommendation for approval.
The researchers also expressed concern over the recently-passed “21st Century Cures Act” which contains provisions intended to reduce medical device regulation that is now being debated in the Senate.
“There are provisions that would broaden the definition of the ‘valid scientific evidence’ manufacturers need in order to prove medical benefit,” said Dr. Jessica Walter, lead author of the study. “Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”
Do I Have an Essure Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Essure birth control side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.