Pharmaceutical

Studies linking Ethicon’s Physiomesh to recurrent hernias and re-operations lead to recall, market withdrawal

physiomesh Studies linking Ethicons Physiomesh to recurrent hernias and re operations lead to recall, market withdrawalThe Daily Hornet reports that American consumers were not warned by the FDA in May that Johnson and Johnson subsidiary Ethicon was removing Physiomesh™ Flexible Composite Hernia Mesh from the market rather than correcting issues with the product. Physiomesh was recalled in Europe and in Australia, but in the United States the company issued a “market withdrawal” of the product, which did not require FDA announcement as a recall would.

Physiomesh was originally approved by the FDA in April 2010 through a 510k submission, which bypassed the extensive safety and efficacy testing required of new products and allowed the product to be cleared because it was “substantially equivalent” to other products on the market. Specifically, Physiomesh was substantially similar to Ethicon’s Proceed mesh, which would be recalled only six months later, in October 2010, due to layers of the mesh separating once implanted.

Ethicon’s recall and market withdrawal of Physiomesh was in response to two large independent studies in Germany and Denmark that found that Physiomesh, when compared to similar devices, had higher rates of recurrent hernias and the need for re-operation.

According to the Daily Hornet, Ethicon already had lawsuits brought against it before the recall, with plaintiffs accusing the company of selling a defective hernia mesh implant. The first trial date set for Jan. 22, 2018, in Illinois.

Physiomesh is a flexible polypropylene mesh designed to reinforce the abdominal wall, preventing future hernias from occurring. Polypropylene is a fibrous plastic product that is also used in the transvaginal mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. The manufacturers of these devices have been sued by tens of thousands of women who allege the mesh can migrate within or erode inside the body, and perforate or puncture organs, causing chronic pain, infections and even death.

Studies of Physiomesh have shown not only that it is related to significantly more recurrent hernias and postoperative pain than similar devices, but it has been linked to an increased risk of additional surgeries, organ perforation, mesh migration, sepsis and even death.

The Daily Hornet encourages hernia patients implanted with Physiomesh to continue follow-up visits with their doctors and to be aware of symptoms of a failed surgery. They list the following injuries to look for: Dense adhesions, No ingrowth, Bowel obstruction, Pain, Hernia recurrence, and Seroma.

Sources:
The Daily Hornet
Beasley Allen
Beasley Allen
US National Library of Medicine
Righting Injustice