In risk-benefit calculation, are fears about Physiomesh valid?

posted on:
November 8, 2017

author:
Matt Munson

matt munson In risk benefit calculation, are fears about Physiomesh valid?The Food and Drug Administration (FDA) says that more than 1 million hernia repairs are performed annually in the U.S. Some within the medical industry say that patients’ fears about the safety of hernia mesh products are getting in the way of the surgeries.

However, Righting Injustice explains that the hernia mesh market is expected to grow to more than $8.5 billion globally by 2022. Therefore, it is important that consumers understand the risks involved with hernia mesh products such as Physiomesh.

Physiomesh is considered a medical device, as Beasley Allen has explained previously. It is manufactured by the Johnson & Johnson subsidiary Ethicon and received FDA approval in 2010, through the 510(k) fast-track process. It was designed and approved to repair and reinforce areas of weak muscle in the abdomen, called hernias. Because it was similar to the company’s Proceed transvaginal mesh, Physiomesh was allowed to forgo the more rigorous clinical safety testing typically required of medical devices before they are approved for the market.

Physiomesh is uniquely designed with five distinct layers of film that coat a layer of mesh made of a flexible plastic called polypropylene. Although the film was intended to reduce adhesion and prevent inflammation, many patients claim that the film layers prevent proper incorporation of the mesh, increasing the risk of infections.

The polypropylene also is known to erode once it is implanted in the patient. The fragmented pieces of eroded Physiomesh can travel through the body perforating organs and causing infections, chronic pain and even death.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established a multidistrict litigation (MDL) in the Northern District of Georgia located in Atlanta in July. At the time, the MDL consolidated nearly 70 cases. In just three months, the JPML reports the number of claims have more than tripled, climbing to 236.

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If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, contact Matt Munson by calling 800-898-2034 or by email at Matt.Munson@BeasleyAllen.com.

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