Bard pulls mesh implants from EU
BD subsidiary C.R. Bard is permanently withdrawing its urogynaecological mesh devices for stress urinary incontinence and pelvic organ prolapse from the European market, the Medicines and Healthcare products Regulatory Agency communicated Thursday.
The company framed the action as a response to the need to invest in clinical data to keep the products on the market once Europe's new device rules comes into force next year.
Mesh implants have been the subject of lawsuits, regulatory scrutiny and investigations around the world in recent years amid reports of adverse events.
Reports of adverse events linked to mesh implants, and accusations that doctors and regulators were slow to respond have led to calls for more medical device oversight, including an ongoing U.K. probe into whether "systemic failures" occurred. These probes have restricted use of mesh implants, shrinking the market opportunity.
While the company maintains that its devices are safe, a confluence of factors means they are no longer attractive economically.
"We have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements," BD said in a statement shared with Sky News.
Under the old and incoming legislation, the European Union treats most implantable and long-term surgically invasive devices as Class IIb products. The key difference, from Bard's perspective, is that the incoming legislation specifically singles out surgical meshes as an exception to the rule. Under the rules that will come into force next year, surgical meshes are Class III devices.
That change, which has been mirrored by Australian authorities, and other aspects of the legislation mean developers of mesh devices will need to perform clinical investigations unless they meet the criteria for exemption. Implantable and Class III devices already on the EU market need “sufficient clinical data” to be exempt from the requirements.
In the U.S., FDA is currently reviewing PMA applications for pelvic organ prolapse mesh products from Boston Scientific and Coloplast, the only two companies seeking to stay in a market that has become more strictly regulated in recent years.
Bard expects to complete the withdrawal within two weeks but it will take longer than that to fully extricate itself from the legacy of its mesh business. As of the end of September, BD was defending more than 1,300 product liability claims involving Bard's line of pelvic mesh devices.