Why has Physiomesh™ Flexible Composite Mesh been withdrawn from the market?

The manufacturer, Ethicon, Inc., a subsidiary of Johnson & Johnson, notified hospitals in 2016 that it was removing the surgical mesh from the market because too many patients who had the mesh implanted were suffering complications and having to have repeat hernia surgeries. By 2016, Physiomesh™ Flexible Composite Mesh had been in use for approximately six years. Hernia repair is a common procedure. Many patients had had Physiomesh™ placed in their abdominal walls to reinforce them. Clear trends in rates of complications emerged in data reported to health registries in two countries, Germany and Denmark. A review of the data from the registries requested by Ethicon’s Product Safety Team showed patients who had Physiomesh™ Flexible Composite Mesh had higher than average rates of complications requiring repeat surgeries. Ethicon said there appeared to be multiple factors involved, but that it could not provide guidance to doctors to address the issue. Therefore, it was withdrawing the product from the market.

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