Surgical Mesh Used for Hernia Repair Withdrawn from Market
In May of 2016, Ethicon issued a global Physiomesh market withdrawal, pulling many varieties of hernia mesh products off the market. Citing nonspecific reasons, Ethicon warned surgeons to stop using Physiomesh in an Urgent Field Safety Notice. Tantamount to an Ethicon hernia mesh recall, the global market withdrawal essentially means the product has been taken off markets worldwide on a permanent basis. Persons and families members of persons having suffered from Physiomesh complications may be eligible for compensation through hernia mesh injury lawsuits against Ethicon.
Surgical Hernia Mesh Safety Warning
Physiomesh has been found to result in higher revision and failure rates than other similar products. Hernia mesh complications include pain, infection, hernia recurrence, adhesion (when a scar-like tissue sticks internal tissues together), intestinal blockage, mesh migration, mesh shrinkage (contraction), and the need for repeat surgeries. Some persons have suffered from severe internal organ damage with lifelong consequences as a result of Physiomesh problems.
Case Study: Hernia Mesh Injuries
A Physiomesh lawsuit has been filed against Ethicon in Illinois by a man who has suffered irreparable internal damage as a result of surgical hernia mesh implantation. The plaintiff underwent abdominal wall surgery after suffering a ventral hernia in 2013. He was implanted with Ethicon’s Physiomesh, which was implanted permanently and intended to be compatible with the abdominal walls.
In 2015, the plaintiff went to the hospital suffering complaints of pain, fever, nausea, chills, and redness on the skin of his abdomen. He was hospitalized for a severe infection causing abdominal abscesses and intestinal fistula, which required surgery to repair. The plaintiff alleges that Physiomesh problems and defects caused the hernia mesh to adhere to his internal organs, which resulted in severe infection and long-term injuries related to two ongoing open wounds inside his abdomen.
The hernia mesh lawsuit asserts the product is “defective, unreasonable dangerous, and not suitable for implantation”. Furthermore, this Physiomesh lawsuit states the hernia mesh was “not reasonably tested to determine if it was fit for its intended purpose of implantation into the human body.”
Physiomesh Market Withdrawal
Physiomesh hernia mesh was first approved in the United States for hernia repair applications in 2010. The product passed animal testing standards, according to documents from the FDA, and no safety alerts were raised at the time. Today, critics say the testing done prior to market approval of surgical hernia mesh was inadequate because it did not test for the specific application, which is internal implantation into the abdominal wall.
When Johnson & Johnson learned of the results of two significant European studies, the company voluntarily chose to issue a Global Market Withdrawal statement. This is basically equivalent to a Physiomesh recall, yet saves face for the company by retracting the device voluntarily. Essentially, Physiomesh risks have been found to outweigh the potential benefits of the hernia mesh.
Hernia Mesh Research
The results of two major unpublished hernia mesh side effects studies were released in 2016. The two studies concluded that when compared to other methods of hernia repair, the use of Ethicon’s Physiomesh causes severe and unnecessary side effects. Specifically, the hernia patch injury studies found that Physiomesh hernia mesh results in high rates of hernia recurrence and the need for revision surgeries. Ethicon responded by issuing an Urgent Field Safety Notice outlining various surgical hernia mesh patch side effects. The company stated that Physiomesh problems were the results of “product characteristics, operative and patient factors” but did not cite a specific product defect.
Based on the hernia repair registries of Denmark and Germany, this research represents the largest examination of Physiomesh dangers to date. Both unpublished, the international studies examined hernia repair outcomes using Physiomesh and other hernia patches throughout Denmark and Germany, respectively.
Lawyers for Hernia Mesh Lawsuits
Our attorneys handling national Physiomesh lawsuits against Johnson & Johnson are available to discuss your case at no cost to you. Our hernia mesh lawyers work on a contingency basis, meaning you pay no legal fees unless we win for you. Visit our full Hernia Mesh Lawsuit website.
Family safety attorneys at OnderLaw, LLC provide superior legal services to families harmed by dangerous drugs and consumer products.