Do life-saving medical devices really work? In 2012, some members of the medical community began openly charging that nobody really knew the answer to that question because the devices were approved by the U.S. Food and Drug Administration (FDA) before they were adequately tested.
In 2012, Consumer Reports investigated that shocking charge. It reported that all manufacturers had to do to get federal approval for medical devices like artificial joints, heart defibrillators or surgical mesh was to file some paperwork and pay a $4,000 fee. According to the publication, the FDA’s approval process turned patients into guinea pigs – in effect,” conducting clinical trials on the American public.”
Thousands of DuPuy hip replacements, transvaginal mesh implants, Guidant defibrillators and Mirena intrauterine devices, have failed, putting victims in danger and costing some their health. Thousands of lawsuits have been filed across the country on behalf of those injured by these devices.
The Wayne Wright law firm has vigorously pursued justice for victims injured by devices that failed to improve their health and subjected them to additional suffering, rather than end their need for medical intervention. Anyone who received one of nearly “28 high risk devices” that the FDA approved between 2010 and 2011 may well be among those needing legal assistance.
Unfortunately, not much has changed in the FDA approval process for medical devices since the charges against the federal agency were investigated by Consumer Reports in 2012.
In 2015, The Huffington Post published an article citing a new study that found most “medical devices go to market with little evidence that they work.” It reported that “high-risk” devices - those that are implanted directly into the body – receive little study of their long term clinical efficacy. The article was based on a paper from a “team at the Yale School of Medicine” that looked into laws governing the FDA’s approval of medical devices.
One of the paper’s authors, Dr. Joseph Ross, a professor at the Yale School of Medicine, says that laws governing the FDA’s approval process stipulate that it can only “require manufacturers to do the bare minimum of research” into the safety of a new medical device before it goes on the market.
Beneficial change is coming in one respect. In 2016, a law requiring all medical devices to have bar codes like other consumer products will be phased in so these devices can then be easily tracked to provide doctors with the information they need to genuinely assess their impact.
Others are urging the FDA to set up registries to monitor the safety and effectiveness of medical devices. Since 2014, The Pew Charitable Trust, the Blue Cross Blue Shield Association and the Weill Cornell Medical College have been urging the FDA to evaluate “the devices in wider populations over longer periods of time…” through registries. They cite the “failures of metal-on-metal hips and implantable cardiac defibrillators…” as proof of the need.
The FDA is currently requesting recommendations from medical experts on how to consolidate information from registries in a central location to make it easily accessible to patients and the medical community.
Meanwhile, the U.S. Congress is considering a law called the 21st Century Cures Act. Unfortunately, it would further reduce the FDA’s already low threshold of approval for medical devices. Researchers at Yale are opposed to the bill.
The Wayne Wright law firm stands ready to help anyone injured by a medical device that was approved under the FDA’s current lax process. No one should have to suffer as the result of laws that fail to protect the American public from devices that received inadequate testing before manufacturers were allowed to sell them to an unsuspecting public.