More than 800 Physiomesh incidents filed with FDA report pain, suffering

posted on:
September 6, 2017

author:
Matt Munson

matt munson More than 800 Physiomesh incidents filed with FDA report pain, sufferingAs Beasley Allen previously reported, the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) for Physiomesh plaintiffs earlier this summer. The JPML reports the number of pending lawsuits has climbed to 92 since the MDL was created. And, with information collected by the U.S. Food and Drug Administration’s (FDA’s) MAUDE reporting system about adverse events involving the product, there is no doubt the claims will continue to rise.

Physiomesh is manufactured by Ethicon, a subsidiary of Johnson & Johnson. According to Righting Injustice, more than 800 negative incidents involving the mesh have been reported to the FDA’s MAUDE. The system allows doctors and hospitals to provide details about adverse events related to medical devices. Since Physiomesh was first approved by the FDA in 2010, medical professionals have reported 839 such events, including injuries and at least nine deaths, naming the mesh device as the culprit.

Physiomesh, considered a medical device, is made of a flexible plastic called polypropylene and is used to repair weak abdominal muscles, called hernias. It is intended to reinforce the weakened area and prevent the hernia from reopening. Yet, once implanted, Physiomesh begins to erode. It has a higher rate of hernia recurrence and re-opening in patients using the device as compared to patients using similar devices.

Two of the more recent lawsuits, consistent with previous lawsuit claims, provide a glaring backdrop of the pain and suffering patients report is associated with the mesh.

Righting Injustice describes Kathy Edward’s plight as she watched her husband suffer numerous surgeries and countless hours of pain after surgeons used Physiomesh to repair a hernia. The device failed to incorporate into William Edwards’ tissue, which resulted in an infection and required a wound vac to prevent the infection from growing worse. The wound never healed and William died from septic shock, respiratory failure and acute renal failure on January 31, 2017 – 19 months after the initial surgery.

An Alabama man’s lawsuit recounts his own torture from the device and explains how it left him with permanent scarring and other injuries, the Daily Hornet explains. Bill Tedford had a hernia repaired in December 2013 with a Physiomesh patch implant. The device was marketed as a hernia repair device that would prevent or minimize the risk of inflammation and adhesions. The device’s design was also purported to incorporate better into the body’s tissues. However, Ted’s lawsuit explains that it “caused or contributed to an intense inflammatory and chronic foreign body response.” Like William and many others, Ted endured a number of surgeries in order to repair the damage caused by the failed Physiomesh patch.

The embattled mesh maker has settled approximately 3,000 lawsuits due to similar problems with a related product – the company’s Proceed polypropylene transvaginal mesh. The settlement came in January 2016 as part of an MDL. It occurred just months before Ethicon issued a Field Safety Notice and quietly withdrew Physiomesh from markets in the U.S., Europe and Australia because of the product’s high failure rate.

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.

Sources:
Beasley Allen
U.S. Judicial Panel on Multidistrict Litigation
Righting Injustice
Daily Hornet

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