Patients walk into a doctor’s office or surgical room assuming that
the products, devices, and equipment involved in their treatment are not
just top quality, but approved by the Food and Drug Administration. But
how often are unapproved, defective devices flying under the radar? Unfortunately,
it may be more often than many people realize.
$110 Billion Industry Fueled by Profit, Not Safety
As an example, a defective knee replacement device, known as the OtisKnee,
was used in numerous procedures before the government put a stop to several
years ago. With more than 18,000 devices sold and an estimated $27 million
made in profits before the official shutdown, it shows just how easy and
profitable it can be for companies to provide this faulty equipment. OtidMed
Corporation, the maker of this device, failed to get clearance from the
FDA for its products before offering it on the market and to providers.
Eventually, the FDA halted the sale of this device, citing that the company
failed to demonstrate the safety and effectiveness of the product. Just
how long did it take the government to shut down the dangerous sell of
these devices? Three years. Yes, for three years these devices were on
the market, causing many patients additional pain.
Sadly, this just further demonstrates the motive for many medical device
manufacturers across the United States. Their priority is profit-not patient
safety-in this $110 billion industry. Many believe that the FDA also fails
to do enough to keep patients safe from these faulty products. Though
OtisMed did recently end up paying for its actions-a total of $80 million
in criminal and civil fines-the need for early recognition of these faulty
products is of growing concern.
If someone doesn’t step up to hold the medical device industry accountable,
it seems patients will only continue to suffer from negligence and
malpractice. Now is the time to
call our firm if you have been a victim!