In a recent New York Times Op-Ed piece, The Editorial Board (representing the opinions of the board, its editor, and the publisher) argues that the US Food and Drug Administration (FDA) may be failing to adequately monitor the products they approve, after several medical devices have caused health problems in patients.
Citing problems associated with products like vaginal mesh, permanent birth control, power morcellators used to shred uterine tissue, a breast implant that has been linked to a rare form of cancer, and other devices, the Board is quoted as saying, “In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.”
According to the article, Dr Jeffrey Shuren, head of the agency office in charge of device regulation, “has suggested that the benefits of bringing innovative products to market quickly are worth the increased risks.” In the article, The Editorial Board says that innovation should not come at the price of patient safety and/or additional complications. Additionally, “regulatory loopholes” that allow companies to claim their products are similar to ones already approved or “updated” without testing them in human trials first, may mean that some devices come on the market without “rigorous testing,” or reporting of all incidents of illness or injury, according to The Editorial Board.
Source: New York Times
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