The writing is on the wall for vaginal mesh products in the US. The FDA has instructed Boston Scientific and Coloplast to stop selling their meshes for transvaginal repair of pelvic organ prolapse (POP), saying there was no proof that their use was an improvement over surgery without them.
The decision prompted respective 4% and 3% drops in Boston’s shares and Coloplast’s ADRs, despite the fact that mesh sales made up only a tiny fragment of either company’s revenues. Perhaps shareholders took the efforts the groups had made to try to convince the FDA as a waste of money.
And tried they had. All the pelvic meshes on the US market have been cleared for sale, over the past several decades, via the 510(k) route. In 2016 the products were reclassified as high risk when used for minimally invasive POP surgery, necessitating a premarket approval (PMA) submission. Rather than gather evidence and apply for approval, almost all of the 30 or so mesh manufacturers, which included Johnson & Johnson and CR Bard, simply stopped selling the devices.
Boston and Coloplast were the only two companies to apply for PMAs – two in Boston’s case, for the Uphold Lite and Xenform products, and one for Coloplast’s Restorelle DirectFix. While the FDA was reviewing these submissions the meshes were allowed to remain on sale.
But now the FDA has turned the submissions down, stating that they failed to demonstrate “a reasonable assurance of safety and effectiveness”. Boston and Coloplast are reported to make around $25m and $6m a year from use of the devices in POP, less than 1% of either company’s overall sales.
The situation in Europe, with its decentralised regulation of medical devices, is, from medtechs’ point of view, arguably more forgiving.
In 2015 the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks recommended that implantation of mesh for the treatment of POP via the vaginal route only be considered in complex cases, and in particular after failed primary repair surgery, or when other surgical procedures have already failed or are expected to fail.
While there is no Europe-wide regulator to demand that device makers stop selling vaginal meshes, the devices could still come to be removed from the market. If marketing authorisation were to be withdrawn by a national regulator the other national authorities would be bound to make the same recommendation.
For example, in December the French national agency for the safety of medicines and health products suspended the CE mark for Allergan’s Microcell and Biocell textured breast implants after these were linked to a rare form of lymphoma.
According to Boston, half of women in the US will experience POP during their lives, and the FDA says about one in eight American women undergo POP surgery, though not all of these procedures are transvaginal.
A variety of surgical meshes are used for other applications too, such as treatment of stress urinary incontinence and hernia repair. These procedures have not been linked with the same adverse events as transvaginal POP repair, and the products will remain on the market.
Meanwhile, the lawsuits relating to vaginal meshes lumber on. According to its 2017/18 annual report Coloplast has spent DKr4.7bn ($712m) to settle US lawsuits alleging injury resulting from the use of transvaginal surgical mesh products. It estimated that more than 95% of known US lawsuits had been settled, and it had a war chest of DKr500m for the rest.
Boston, meanwhile, spent $103m on litigation, primarily in connection with transvaginal surgical mesh claims, in 2018 alone. As of February 5 around 53,000 product liability cases or claims related to transvaginal mesh products had been asserted against Boston, and the group had entered into or was finalising agreements to resolve approximately 50,000 of these. None of these agreements saw Boston make any admission of any liability or wrongdoing.