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Amid continuing concerns about the risk of severe and painful complications from transvaginal mesh, Australian regulators have decided to ban use of the products for repair of pelvic organ prolapse in the country, indicating that the risks outweigh any likely benefits.
The Therapeutic Goods Administration (TGA) announced the transvaginal mesh ban in a press release on November 28, specifically targeting surgical mesh used for the treatment of pelvic organ prolapse. The ban also includes products known as mini-slings, which are used to treat stress urinary incontinence.
The decision came following a review of the safety and effectiveness of pelvic mesh products. The TGA noted that since the review commenced in 2013, 45 transvaginal mesh have been removed from the market in Australia; not including those removed for commercial reasons.
The TGA notified Boston Scientific and Coloplast, the only transvaginal mesh manufacturers left in Australia, that their transvaginal mesh devices will be removed from the Australian Register of Therapeutic Goods as of January 4, 2018.
In the U.S., more than 100,000 product liability lawsuits have been filed against Ethicon, Boston Scientific and other manufacturers of transvaginal mesh products used for repair of pelvic organ prolapse and female stress urinary incontinence. Design defects associated with surgical mesh have been linked to severe complications among women, including infections, erosion of the mesh into the vagina and organ perforation.
The litigation over vaginal mesh products was one of the largest mass torts in recent years, with tens of thousands of women filing cases nationwide.
Following several years of litigation, various different manufacturers have reached vaginal mesh settlements to resolve groups of claims involving problems with products manufactured by Endo’s AMS, C.R. Bard, Boston Scientific, Ethicon and others.
The number of cases began to increase rapidly after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.
After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women. Since then, a number of manufacturers have decided to stop making the devices to avoid the need to spend money studying the safety of products they have sold for years.
Australian health officials say that the data on transvaginal mesh products is still of fairly low quality and does not appear to show any significant health benefits.