BioMatrix Medical has initiated a voluntary recall of its ProLift surgical mesh implant used in hernia repair procedures after post-market surveillance identified higher-than-expected rates of tissue erosion complications. Approximately 8,000 implants have been distributed to hospitals since mid-2025.
The FDA received 34 adverse event reports describing tissue erosion, chronic pain, and infection at the implant site. BioMatrix is working with surgeons to identify affected patients and develop individualized monitoring plans based on implant date and patient risk factors.
The recall adds to the troubled history of surgical mesh products, which have been the subject of thousands of lawsuits and multiple previous recalls. Patient advocacy groups are urging stronger pre-market testing requirements for implantable medical devices.
