The present batch of vaginal mesh implants had been cleared for sale and distribution by the Food and Drug Administration (FDA) through its 510(k) pre-notification process, reports Bloomberg. Under this provision, a medical device may be cleared for distribution as long as it is “substantially equivalent” to a predicate product.
The predicate product in this case, based on the same report, is the ProteGen Sling manufactured by Boston Scientific. Originally intended for the treatment of stress urinary incontinence (SUI), it was never in the market for long since this was recalled in 1999 due to its high failure rate. The FDA even labeled this product as “misbranded” and “adulterated,” according to a report by the New Jersey Star-Ledger in 2002.
What many may find very puzzling is why these new vaginal mesh devices were even cleared in 2004 when the product it was supposed to be substantially equivalent was recalled five years earlier due to it high complication rates. This decision would certainly raise a lot of questions. Were they motivated by other factors? Whatever it is, the fact remains that because of this decision, millions of women will continue to suffer and may live the rest of their lives in misery.