What is Physiomesh?
Physiomesh is a type of surgical mesh used to stabilize and strengthen tissue around hernias to prevent the hernia from reopening. The product was introduced to the market in 2010 and was intended to be used in abdominal surgeries and hernia repair.
The mesh is constructed of an artificial plastic, polypropylene, which was used to minimize inflammation. The mesh has been known to disintegrate and cause infection, swelling at the surgical site, and hernia recurrence in some patients.
Physiomesh, like many medical devices and drugs, was approved via the FDA’s 510(k) short-cut process. This means the product became available to consumers without a thorough evaluation because it was similar to a product already on the market.
Those who underwent procedures that utilized Physiomesh may experience:
- Severe pain
- Abdominal swelling
- Bacterial infection
- Bowel obstruction
- Bowel adhesion
- Hernia recurrence
- Mesh migration
- Organ obstruction
- Need for follow-up surgery
Hernia repair surgery is painful and requires a significant period of recovery. In most cases, hernias can be repaired with a single procedure, but those who underwent repair surgery that initially utilized Physiomesh had a higher rate of relapse. Follow-up procedures to correct the original surgery are very risky and require a longer recovery period.
According to data from the FDA, Ethicon’s Physiomesh Flexible composite surgical mesh has a higher than normal rate of triggering hernia recurrence and a need for follow-up surgery. The product was pulled from the market in May 2016, but not until after many people were injured by the product.
As a result, several Physiomesh lawsuits have been filed against Ethicon and Johnson & Johnson.
Following numerous reports of hernia recurrence for those using Physiomesh, Ethicon voluntarily withdrew the product from the market in May 2016. Problems with the mesh were confirmed via analyses of two separate registries of hernia patients.
The FDA issued a safety announcement at the same time as the Physiomesh withdrawal and encouraged doctors and surgical facilities to remove the mesh from their inventory.
Though the recall of Physiomesh was a good faith measure by Ethicon, it was too late for many who had already undergone procedures that utilized the product and had hernia recurrence. Those who have yet to experience a problem but are implanted with Ethicon’s Physiomesh are still at risk.
As of this writing, there are still patients who have not yet experienced complications and still have the recalled mesh inside their bodies. These patients may still be at risk for developing serious complications related to the implanted Physiomesh.
The US Food and Drug Administration (FDA) did not issue any Physiomesh recall and did not include hernia mesh in its list of recalled products in 2016.
Thousands of lawsuits have been filed against the manufacturer of Physiomesh and are pending in several federal districts. Cases across the United States are listed in states including Georgia, New Jersey, Florida, and more. The first Physiomesh trial was last November 2020 while the 2nd and 3rd trials were in 2021.
Some of the cases are:
- US District Court for the Middle District of Florida, Orlando Division: A woman who was implanted with mesh in 2014 and experienced hernia recurrence just one year later
- US District Court in Massachusetts: A man received Ethicon’s Physiomesh during a laparoscopic repair in 2013 and was forced to undergo one follow-up surgery that same year and then again in 2015
- US District Court of Illinois: A man received Ethicon’s Physiomesh for hernia repair in 2013 and required follow-up surgery two years later. The lawsuit was filed in 2016.
Lawsuits involving Physiomesh include allegations regarding Ethicon’s failure to warn about the risks of Physiomesh, defective design, manufacturing, and labeling, and negligence theories of discoveries. These lawsuits include claims of potential damages from a defective medical device and might include compensation for the following:
- Medical bills
- Lost wages
- Lost earning capacity
- Pain and Suffering
- Emotional distress
- Corrective surgeries
If you or a loved one experienced problems or serious complications linked to the use of Ethicon Physiomesh, you may have a right to take legal action.
If any of the following apply to you, you could be eligible for financial compensation:
- Hernia surgery between March 1, 2010, and May 31, 2016
- Laparoscopic hernia procedure
- Surgery to treat ventral or abdominal hernia
A global settlement has been filed for the Ethicon Physiomesh but there are no clear settlement cases reported. The amount of the settlement has not yet been disclosed, so there are no known individual settlement amounts.
If you underwent a hernia repair procedure that utilized Ethicon’s Physiomesh, you should contact an attorney as soon as possible. Seeger Weiss has a team of attorneys who can evaluate your case.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.