Throughout the Commonwealth and the United States, manufacturers of medical mesh are coming under fire for widespread device failures and questionable business practices. Many mesh devices used to treat incontinence, hernias, or prolapses have already been recalled throughout the United States, the United Kingdom, Australia, and Canada. The medical mesh market has a fast-paced product development landscape, and is estimated to be worth roughly $1bn globally.
The most recent medical mesh scandal involves Boston Scientific, the subject of a 60 Minutes investigation. Boston Scientific has come under fire after losing access to its supply of plastic used in the production of the vaginal mesh devices. Its supplier, Chevron Phillips, halted production of the plastic for medical applications due to product liability concerns, after it was found that it degraded in the human body and should not be used for permanent implantation.
Using an alternative plastic would have required Boston Scientific to seek new FDA approval for its device, so it resorted to sourcing plastics from an unverified Chinese company. The company claims the Chinese plastic is the same as its original material, a stance backed by the FDA. However, leaked internal emails admitted that Boston Scientific was unable to trace the provenance of the plastics it had purchased and needed to obscure the purchase from customs agents while shipping the products to the United States.
Boston Scientific’s mesh scandal is perhaps the most recent example of questionable devices being pushed to the market, but they are far from alone. Ethicon’s TVT-Secur implant was found to have been tested in sheep and a small sample of 31 women before being brought to market. Despite consultants advising the company to perform more robust clinical tests, the company went ahead with sales and unsurprisingly, had to recall the device in 2012. Ethicon, J&J, Bard and Boston Scientific have all had to pull mesh devices that were known to cause pelvic pain, organ damage, and other serious complications but continued to push sales of similar devices.
In Australia, the use of vaginal mesh has been banned for most procedures, and the UK is soon to follow suit after the NHS was found to have ignored advice from watchdogs to limit use. Unfortunately in the US, where there have been over 100,000 vaginal mesh lawsuits filed, there is little likelihood that the FDA will ban this device. The FDA has previously rejected suits petitioning for the ban of transvaginal mesh, and continues to allow for the use of non-medical grade plastics in these implants.
While the US is the largest market for medical mesh, GlobalData expects that this market will be negatively affected by the pattern of bans being introduced in other countries. However, the medical mesh market is quickly changing due to innovation and the introduction of new technology, which may lead to safer versions of currently marketed devices. Hernias, incontinence, and organ prolapses are widespread ailments providing a high-opportunity market.
For more insight and data, visit the GlobalData Report Store – Verdict Medical Devices is part of GlobalData Plc.