Recalls for Higher Failure Rates of Ethicon Physiomesh. Johnson & Johnson is issuing a voluntary recall of its Ethicon Physiomesh, which is used for hernia repairs. According to an “Urgent Field Safety Notice”, the device is being recalled due to higher than expected failure rates. J&J’s action was based on unpublished data from two large independent hernia registries, one in Germany and the other in Denmark. The data showed that laparoscopic ventral hernia repair with Ethicon Physiomesh Composite Mesh was associated with higher recurrence/reoperation rates compared to the average rates of comparator set of meshes among patients in these databases.
The company said it was unable to give recommendations on how to reduce the risk of recurrence. Ethicon states in the notice, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.” The U.S. Food and Drug Administration (FDA) has been notified of the issue.
J&J, along with other device makers, has faced substantial litigation over mesh products in the past. The base layer of the Physiomesh is made of polypropylene, the same material used in transvaginal mesh and slings. The Physiomesh is used for minimally invasive abdominal and groin hernia repair. Pelvic mesh is used to treat stress urinary incontinence and pelvic organ prolapse.
Failed Warning of Serious Complications
Plaintiffs in the transvaginal mesh litigation alleged that device makers failed to warn about the risk of mesh erosion and other serious complications. A number of women alleged that they underwent a number of procedures to remove the embedded mesh, but the attempts were still not successful. Lawsuits alleged that J&J did not clinically test the devices for safety or efficacy because they were approved through 510(k), which allows devices onto the market without clinical testing if manufacturers can show that the devices are “substantially equivalent” to an older device on the market. Ethicon Physiomesh was also approved through this process in October 2014.
In light of numerous complaints and safety concerns, the FDA has reclassified transvaginal mesh products as high-risk. This means that the devices can no longer go through 510(k); they must be approved through the stricter pre-market approval process, which mandates clinical testing for safety and efficacy.
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