The FDA first approved surgical mesh to treat stress urinary incontinence (SUI) in 1996, later expanding the approval to include pelvic organ prolapse (POP). The approval was accomplished through the FDA’s 510(k) system, which provides an expedited process for products that are similar to others already on the market. The similar devices in question were mesh products used for hernia and other abdominal repairs. The intervening years tell a tale of unraveling confidence in both the safety of transvaginal mesh and the soundness of FDA’s approval process.
By 2011, the FDA warned that serious complications associated with surgical mesh for transvaginal repair of POP were not rare and that it could expose patients to greater risk without substantial medical advantage. Manufacturers like Boston Scientific, Mentor Corporation and C.R. Bard pulled products from the market.
A 2017 study published in the journal The BMJ directed blame squarely at the FDA, concluding that, “Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years.” More bluntly, as Dr. Malik put it, “there is no evidence that this stuff is any good.”
Meanwhile, however, as Dr. Malik notes, women continue to suffer from transvaginal mesh side effects, including ongoing pain, chronic infections, bladder infections, difficulty having sex, trouble passing urine, incontinence, and erosion into the vagina or the pelvic area, sometimes leading to organ rupture.
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Dr. Malik represents individuals in personal injury cases through his law office, The Dr. Shezad Malik Law Firm, in Dallas, TX.