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After a review of unpublished data from two European healthcare registries, Ethicon informed healthcare providers in a letter dated May 25, 2016 that it will pull the mesh product.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:
MARCH 2017 UPDATE:
Our firm has a long history of successfully representing patients with polypropylene mesh related injuries. For nearly a decade, we have represented thousands of women with transvaginal mesh related injuries including incurable, severe pelvic pain caused by acute and chronic inflammation and foreign body response. Medical literature, testimony from both treating and expert surgeons, doctor testimony have confirmed that the excessive inflammation and resulting tissue contraction, mesh erosion, infection and other complications were caused by defective design characteristics of transvaginal mesh. Among these design flaws, it has been argued that the mesh was not lightweight nor porous enough to allow for timely and healthy tissue incorporation into the host tissues of women’s pelvic floors and surrounding tissues. The manufacturers of transvaginal mesh, of note, directed the medical industry and the FDA to the prior clearance for sale of hernia mesh in its bid to bring mesh to market for vaginal indications. These manufacturers relied on alleged similarities with hernia mesh, without performing any clinical trials to examine and test safety and efficacy. Manufacturers prevailed, leading to one of the largest products liability cases in history. Today, much of the transvaginally placed mesh is no longer sold. Unfortunately, we believe that many of the design flaws that were revealed in the transvaginal mesh litigation are incorporated into hernia mesh sold today. Irrespective of the intense scrutiny placed upon their past practices, we believe that accumulated evidence gained during our investigations will show that these companies made many of the same mistakes and have failed to take timely corrective action. We further believe that these manufacturers, including Atrium (now known as Getinge Maquet), Ethicon, Covidien and Bard, rushed products to market in an attempt to compete in the competitive marketplace of hernia mesh.