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!