The FDA has been challenged by the lack of regulation and oversight for medical devices. A Northwestern Medicine study suggests that new regulations are needed to bring accountability back into device manufacturing, which could save thousands of lives and billions in taxpayer dollars.
The “what does the fda do” is a study that highlights flaws in FDA device regulation. The study was conducted by Northwestern Medicine and it found that there are many cases where devices are approved without any clinical trials, or with insufficient data.
Most women believe that medical devices used in obstetrics and gynecology are fully examined before being approved for use in mainstream medicine. A recent Northwestern Medicine research, on the other hand, explains why trust in the regulatory process is misguided and how harmful gadgets may find their way into the market and into women’s bodies.
“Despite the fact that there have been several safety concerns with OB-GYN devices that have affected millions of women throughout the globe, the data that led to approval contains a number of flaws.”
Due to high rates of problems, some obstetrics and gynecology medical devices, such as Essure permanent birth control, laparoscopic power morcellators, and transvaginal mesh, have been the focus of current criticism (as well as litigation). According to Northwestern University researchers, all of these gadgets had one thing in common: they were authorized by the FDA based on faulty evidence.
The researchers examined 18 high-risk OB/GYN medical devices licensed between 2000 and 2015 and discovered the following:
- Despite failing to establish effectiveness in clinical trials, four devices were authorized.
- Six gadgets were exempt from postmarket monitoring to ensure their continued safety.
- Nonrandomized controlled trials were used to approve almost half of the devices (randomized controlled trials are considered the “gold standard” of clinical studies).
- Three devices were pulled off the market; two of them were not assessed by the FDA’s obstetrics and gynecology advisory committee, and the third was reviewed but not recommended for clearance.
Dr. Steve Xu, the study’s principal author, said, “We looked at the class of devices with the biggest potential danger to patients—the devices that had to go through the most stringent pre-market clearance procedure.” “Despite the fact that this is the most restrictive route, and despite the fact that we’ve had several safety concerns with OB-GYN devices impacting millions of women across the globe, the data leading to approval contains a number of flaws.”
Essure’s Failings Have Been Revealed by Researchers
Bayer’s Essure permanent birth control was highlighted by the researchers as an example of how flaws in the FDA medical device approval process might lead to human damage.
According to the research authors, Essure was authorized in 2002 based on short-term data and insufficient post-market follow-up. More than 10,000 injuries have been connected to it, including severe pain, organ damage, and unplanned pregnancy.
“For medical devices, there are no clear requirements for performing randomized-controlled trials or post-market monitoring.”
9% of women experienced adverse reactions in one premarket study used to approve Essure, however the device was authorized despite the fact that no pregnancies were recorded during testing. Although the FDA authorized post-approval studies for Essure, the New England Journal of Medicine reported that these studies had major flaws, including short follow-up periods, the omission of critical data, and the absence of a comparison group (i.e. a controlled study).
Bayer’s Essure device has a substantially greater failure rate than pre- and post-marketing statistics suggest, according to independent, controlled research.
In March 2016, the FDA ordered that Essure be labeled with a “black box” warning and that Bayer do fresh tests on the device.
“For medical devices, there are no formal requirements for performing randomized-controlled trials or post-market monitoring,” Dr. Xu stated. New medicine approval is subject to substantially stricter requirements. Should we really be subjecting high-risk medical devices to a lesser standard of proof than drugs?” is an essential topic to consider.
Filing a Lawsuit Against Essure
There is a need for more stringent device regulation.
Even as legislation opposing this is making its way through Congress, the study team stressed the need for further oversight of medical devices.
The House of Representatives approved the 21st Century Cures Act in May 2015, and the Senate is presently considering it. It has a wider definition of “valid scientific evidence.”
“Our fear is that this will lead to more devices being authorized with even less clinical proof that they are both safe and effective,” research author Jessica Walter said.
Both clinicians and the FDA, according to Walter and Xu, have a role to play in bringing higher-quality research into the device approval process. They went on to say that data suggests that greater regulation does not always imply less innovation.
In the June 2016 issue of Obstetrics and Gynecology, “Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems” is published.
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