KEY TAKEAWAY: Via the NY Times “makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress”. This is not the way to ensure medical device companies stay compliant.
The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday.
The current draft compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever. But, at a time when the F.D.A. acknowledges that medical device mishaps are vastly underreported, a provision in the bill says the agency should permit companies to report malfunctions every three months, rather than the current practice of submitting reports within 30 days of a problem.
Can you say “very bad idea”!
Medical device companies get away with some very questionable marketing. Arthrex, for example, paid physicians over $60 million in 2016 and Stryket, the leading knee replacement device maker paid over $63 million to doctors.
Is it any wonder that doctors are quick to say you need a knee replacement. Between 1991 and 2010, the incidence of knee replacements increased by over 161% and one has to wonder just how many of these surgeries are being influenced by payments to physicians. More than 640,000 knees are replaced with artificial joints each year in the United States, at a total cost of about $10.2 billion.
In a the study of 4,500 folks who had a knee replaced due to arthritis they found that the surgery has “minimal effects on quality of life.” There were some improvements in pain, stiffness, and function — but mostly in folks with the most severe form of arthritis. For everyone else, the study finds the operation is “economically unjustifiable.”
The medical device industry should be subject to the same oversights as the pharma industry, but they already have enough politicians in their pocket to put patients’ lives at risk and add to our financial woes.