Hernias are a relatively common problem that for many requires surgery to alleviate daily pain, discomfort and other symptoms. Unfortunately, some who were promised a solution in Ethicon Physiomesh® Flexible Composite hernia mesh, instead found themselves facing potential infections, hernia recurrence and more surgeries. Johnson & Johnson recalled the mesh in May 2016 following its review of unpublished studies that showed a higher failure rate of the Ethicon hernia mesh compared to that of other, similar hernia repair devices. The voluntary recall came in May 2016 after Ethicon, a Johnson & Johnson subsidiary, approached a pair of observational hernia repair registries seeking an analysis of the product’s success rate. The registries, Herniamed German Registry and Danish Hernia Database, determined that the Ethicon device failed at higher rates compared to that of similar hernia mesh repairs.
While neither study was published, key details were made public in removal notices released by Johnson & Johnson. Patients with the Ethicon device suffered above average hernia recurrence and reoperation rates following laparoscopic procedures, according to the notice. “Based on the currently available data, we believe the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors,” Johnson & Johnson stated, instructing surgeons worldwide to cease using the device as no remedy was readily available.
Whether implanted laparoscopically or through open surgery, mesh devices are commonly used to strengthen weakened or damaged tissue in hernia repair procedures. The flexible sheets, which can be synthetic or animal-tissue based, grew in popularity as a hernia repair technique throughout the 1980s, and accounted for roughly 90 percent of procedures by 2000, according to the FDA. The devices are believed to minimize time spent in surgery as well as recovery. If defective, however, they can cause severe complications. Ethicon Hernia Mesh was made of non-absorbable polypropylene and complications can include:Pain-Swelling-Adhesions-Obstructions-Mesh migration-Bacterial infections-Hernia recurrence-Additional surgeries to treat a hernia recurrence
If you or someone you know have developed these complications after Hernia Mesh surgery, contact our firm to learn more about your legal options. You may be able to file a lawsuit against the company, and be compensated for your medical costs and pain and suffering. Call attorney Jamie Sheller at 1 800 883 2299.