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Johnson & Johnson recalled the mesh in May 2016 following its review of unpublished studies that showed a higher failure rate of the Ethicon hernia mesh compared to that of other, similar hernia repair devices.
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 Food and Drug Administration. 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 from its use may include:
• Mesh migration
• Bacterial infections
• Hernia recurrence
• Additional surgeries to treat a hernia recurrence
Two unpublished analyses conducted by Herniamed German Registry and Danish Hernia Database determined Ethicon’s hernia recurrence and reoperation rates were higher than average.
As a result, in May 2016, Johnson & Johnson voluntarily recalled the Physiomesh flexible composite mesh and in letters to healthcare providers stated that it had, “…not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market.”
Ethicon Hernia Mesh was first approved in April 2010 under FDA 510(k) clearance, meaning it did not require FDA review or clinical trials to evaluate its safety before being placed on the market.