Ethicon, a New Jersey-based subsidiary of Johnson & Johnson, voluntarily withdrew a surgical mesh product in May following studies that showed higher rates of revision surgery. The product is called Physiomesh, and is often used in minimally-invasive hernia repair surgeries.
After a review of unpublished data from two European healthcare registries, Ethicon informed healthcare providers in a letter dated May 25, 2016 that it will pull the mesh product. The data revealed discrepancies between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.
Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but the company has not been able to identify an exact cause.
Ethicon voluntarily ceased all sales of Physiomesh Composite mesh throughout the United States. The product is not part of an official “recall” in the U.S., however, internationally, Ethicon issued a notice of recall letter to medical providers in other countries. The letter reads, “consequently, Ethicon [has] 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 will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
The company advised patients that are already implanted with the device to be followed by their doctors as usual. The company also pointed out that the voluntary withdrawal does not involve any other Ethicon meshes, including that Physiomesh Open flexible composite mesh.
“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company said.
If you or a loved one were implanted with Ethicon’s Physiomesh product and have required additional revision surgeries, contact the attorneys at Aylstock, Witkin, Kreis & Overholtz today. There is no fee unless we recover for you.
Read the complaint documents in PDF format below: