The medical device industry is a booming $350 billion a year business in the United States. Through their relentless lobbying efforts and campaign contributions, medical device manufacturers are seeing success at maximizing their profits by gradually eroding the safeguards that should protect the public from defective and unsafe products.
The FDA: Helping Medical Device Manufacturers Increase Their Profitability
In comparison to the FDA approval process that most new drugs undergo, many medical devices that are deemed ‘low to moderate risk’ enter the market without testing, through what’s known as the 510(k) or premarket notification approval process. Essentially, this approval allows manufacturers to fast-track a product to market based on its similarity to an existing device. A major flaw in the process is that it doesn’t matter if the similar device has been pulled from the market due to safety issues. New devices are not subject to the same recall, leaving the public vulnerable to unnecessary risk from the poor original design. While numerous organizations are calling for a re-evaluation and slow down of the approval process, the medical device industry lobbyists continue to push Congress to have the FDA make the process even more streamlined.
When Patients Are The Ones Who Suffer
Medical devices include a vast array of products including hip and knee joints, coronary stents, pacemakers, defibrillators, devices used in cancer treatment, pelvic mesh implants, infusion pumps and even surgical clips. The FDA approves thousands of new products annually, but hundreds of other products are recalled each year due to faulty designs or other safety concerns.
There are numerous tragic stories that demonstrate what happens to patients when the medical device industry and the FDA fail them. One horrific example is the pelvic mesh implant surgeries that thousands of women have undergone believing that the devices allowed on the market were safe. In various lawsuits that have been filed against manufacturers, women claimants state that they’re enduring severe and constant pain as the mesh digs into their tissues and organs. Some have had organs punctured and shredded by the implant, while others have experienced unsolvable urinary retention. Once the mesh is implanted, scar tissue grows into and around it, making it impossible to successfully remove the material to relieve any of the devastating side effects.
Quick Approvals Equate to Higher Profits for Manufacturers
Pelvic mesh products are profitable. One manufacturer, Johnson and Johnson, sold more than $108 million of their pelvic mesh devices between 2005 and 2012. Even though the company knew that the use of their product could have dire consequences for some women, they neglected to include the possible complications in their warnings. With a rapid FDA approval of the device, it was into the hands of doctors across the country quickly, which made it profitable faster. The company has recently taken their product off the market, but not before the lives of American women have been shattered.
Should Profit Trump Patient Safety?
While Americans understand that companies exist to create profit, corporate greed should not be allowed to interfere with ensuring the safety and well-being of individuals who require medical care. The FDA needs to take steps to increase the accountability of medical device manufacturers, rather than making the approval process easier. Medical device product recalls are on the rise, which indicates that the existing approval system is flawed, and worse, inherently dangerous.
If you believe you’ve been suffering due to a faulty medical device, contact our office for a consultation.