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Physiomesh Lawsuits

Ethicon has been one of the leading manufacturers of hernia mesh. Its brand Physiomesh is a partially absorbable surgical mesh for hernia repair and has made billions of dollars in revenue. Patients have filed lawsuits against its manufacturer Ethicon and its parent company Johnson & Johnson on claims of high failure rates for patients.

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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.

Did Physiomesh Cause Serious Side Effects?

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

Were Corrective Surgeries Needed After Physiomesh Implantation?

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.

Why Are People Filing Physiomesh Lawsuits?

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.

Was There a Physiomesh Recall?

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.

Did the FDA Recall 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.

What Physiomesh Lawsuits Are There?

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.

What Are the Claims in the Physiomesh Lawsuits?

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

Who Qualifies to File a Physiomesh Lawsuit?

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

What Physiomesh Lawsuit Settlements Have There Been?

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.

How Do I Find a Physiomesh Attorney?

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. 

Sources

  1. Center for Devices and Radiological Health. (n.d.). Hernia surgical mesh implants. U.S. Food and Drug Administration. Retrieved September 15, 2022, from https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
  2. In re: Ethicon Physiomesh flexible composite hernia mesh products liability litigation. In RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation | Northern District of Georgia | United States District Court. (n.d.). Retrieved September 15, 2022, from http://www.gand.uscourts.gov/17md2782
  3. Perriello, B. (2016, June 20). J&J’s Ethicon recalls physiomesh flexible composite hernia mesh. MassDevice. Retrieved September 15, 2022, from https://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
  4. Sanders, B. (2019, March 6). Hernia mesh litigation mounts. NH Business Review. Retrieved September 15, 2022, from https://www.nhbr.com/hernia-mesh-litigation-mounts/

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