Physiomesh Lawsuit – Hernia Complications

Ethicon physiomesh lawsuitCan I sue Johnson & Johnson because of hernia caused by Physiomesh?

Patients treated with surgical mesh made by Ethicon and Johnson & Johnson are filing lawsuits against the companies because of side effects.

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 its parent company, Johnson & Johnson.

What is Physiomesh?

Physiomesh is a type of surgical mesh used to stabilize tissue. Some surgical mesh products have been very successful, but this was not the case with Ethicon’s Physiomesh.

The mesh is constructed of an artificial plastic, polypropylene, which was used to minimize inflammation. However, it appears the mesh actually triggers inflammation and causes hernia recurrence in some users.

Those who underwent procedures that utilized Physiomesh are at risk for:

  • Severe pain
  • Abdominal swelling
  • Bacterial infection
  • Bowel obstruction
  • Bowel adhesion
  • Hernia recurrence
  • Mesh migration
  • Organ obstruction
  • Need for follow-up surgery

The product was introduced to the market in 2010 and intended to be used in abdominal surgeries and hernia repair.

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.

Ethicon Withdraws Physiomesh, FDA Issues Safety Alert

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 withdraw 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.

Painful Hernia Repair

Hernia repair surgery is painful and requires a significant period of recovery. Follow-up procedures to correct the original surgery are very risky and require a longer recovery period.

In most cases, hernias can be repaired with a single procedure, but those who underwent repair surgery that utilized this mesh had a higher rate of relapse. Many needed painful and risky follow-up procedures to correct the damage caused by Physiomesh.

Physiomesh Lawsuits

There are currently several Physiomesh lawsuits pending in United States courts, including ones in:

  • 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

If you or a loved one had problems linked to the use of Ethicon Physiomesh, you have a right to take legal action. If any of the following applies 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

Lawsuits include claims of injuries from a defective medical device and might include compensation for medical care, lost wages, and pain and suffering. If you underwent a hernia repair procedure that utilized Ethicon’s Physiomesh, you should contact an attorney as soon as possible.

View Sources
  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141560
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093932
  3. https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf
  4. https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141560.pdf
  5. https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf