Physiomesh Lawsuit | 2025 Latest Updates

Ethicon has withdrawn its Physiomesh hernia patch after it was linked to an increased risk for revision surgery and hernia occurrence. Physiomesh was approved via the FDA’s 510(k) loophole, which approves devices that are ‘substantially equivalent’ to existing products.
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If you or a loved one experienced complications, injuries, or hernia recurrence following hernia repair surgery with Physiomesh, you may be entitled to pursue compensation.

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Physiomesh Lawsuit Overview

Physiomesh is a sterile, low-profile, flexible composite mesh designed to repair hernias and other fascial deficiencies. Polypropylene is the same material that makes their  Ethicon transvaginal mesh and bladder slings, except that it contains an absorbable film coating on each side which is composed of slightly different compounds.

Ethicon Physiomesh Flexible Composite Mesh lawsuits allege the product is defectively designed, manufactured, or labeled, causing severe complications such as hernia recurrence, chronic pain, infections, adhesions, mesh migration, and organ perforation. In May 2016, Johnson & Johnson’s Ethicon division voluntarily withdrew Physiomesh Flexible Composite Mesh for laparoscopic use from the global market after studies from German and Danish hernia registries showed higher-than-average recurrence and reoperation rates compared to other meshes.

See more: Hernia Mesh Patch Lawsuit

Latest Physiomesh Lawsuit Updates

December 6, 2023 According to MedTech Dive, Ethicon’s recent settlement has resulted in the dismissal of over 200 Physiomesh lawsuits, signaling progress in resolving claims tied to complications such as mesh failure and adhesion [1].

March 12, 2025 Morgan & Morgan notes that Ethicon’s Physiomesh was voluntarily withdrawn from the market due to high complication rates, and thousands have since filed lawsuits claiming serious health consequences.

Read AlsoBard Composix Hernia Mesh Lawsuit

FDA Reports and Statistics

The FDA’s MAUDE database has received thousands of adverse event reports for Ethicon Physiomesh Flexible Composite Mesh from 2010 to 2016, including infections, mesh failures (e.g., hernia recurrence), bowel perforations, chronic pain, and adhesions, many requiring revision surgeries. In May 2016, Ethicon voluntarily withdrew Physiomesh Flexible Composite Mesh for laparoscopic ventral hernia repair from the global market after unpublished data from German and Danish hernia registries showed higher-than-average recurrence and reoperation rates.

FDA MAUDE reports, documenting thousands of complications like infections, mesh failures, and perforations, highlighted safety issues but were not cited as the primary reason for withdrawal. The withdrawal affected the following product codes: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R [2].

Here, individualized issues for each plaintiff will eclipse any purported common ones, making an MDL ineffective at narrowing claims and issues, Ethicon stated in response to a motion by plaintiffs to centralize the complaints.

Physiomesh Injuries & Side Effects

Physiomesh has been linked to numerous serious complications that can require additional surgeries and cause long-term health problems for patients.

  • Infections: Bacterial contamination requiring antibiotic treatment or surgical intervention
  • Dense adhesions: Abnormal tissue connections between organs that can cause pain and bowel obstruction
  • No ingrowth: Failure of body tissue to incorporate the mesh, leading to instability
  • Bowel obstruction: Blockage of the intestines causing severe pain and potential life-threatening complications
  • Chronic pain: Persistent discomfort that can significantly impact quality of life
  • Hernia recurrence: Failure of the repair requiring additional surgery
  • Seroma: Buildup of fluids under the skin that may require drainage

Do You Qualify for a Physiomesh Lawsuit?

You may qualify for a Physiomesh lawsuit if:

  • You underwent hernia repair surgery with Physiomesh Flexible Composite Mesh
  • You experienced serious complications such as infection, pain, hernia recurrence, or bowel obstruction
  • You required revision surgery or other medical treatment due to Physiomesh complications
  • You can provide medical documentation linking your injuries to the Physiomesh product

Evidence Required for a Physiomesh Lawsuit

To strengthen your Physiomesh lawsuit, you will need to provide:

  • Medical records confirming the use of Physiomesh during your hernia repair surgery
  • Documentation of complications experienced after the surgery
  • Records of any revision surgeries or additional treatments required
  • Medical expert testimony linking your injuries to the Physiomesh device

Damages You Can Recover

Victims of Physiomesh complications may be eligible to recover compensation for:

  • Medical expenses, including costs of revision surgeries and ongoing treatment
  • Lost wages and diminished earning capacity
  • Pain and suffering, both physical and emotional
  • Punitive damages against the manufacturer in cases of egregious misconduct

Physiomesh Recall Information

In May 2016, Ethicon issued a voluntary global market withdrawal of Physiomesh Flexible Composite Mesh for laparoscopic ventral hernia repair. The action was not classified as a recall in the United States, where Ethicon termed it a market withdrawal, but it was treated as a recall in countries like Australia, Canada, and parts of Europe, where regulators issued hazard alerts and recall notices. Ethicon’s May 25, 2016, notice stated: ‘Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.

Consequently, Ethicon has not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and has decided to withdraw ETHICON PHYSIOMESH Composite Mesh from the global market.’ The decision followed unpublished data from German and Danish hernia registries showing elevated recurrence and reoperation rates.

Statute of Limitations for Physiomesh Lawsuits

The statute of limitations for filing a Physiomesh lawsuit varies by state, typically ranging from 1-6 years from the date of injury or from when you reasonably should have known that Physiomesh caused your injuries. Because these timeframes can be complex and vary by jurisdiction, it’s crucial to consult with an attorney as soon as possible to preserve your legal rights.

Related Articles:

FAQs

1. What is Physiomesh Flexible Composite Mesh?

Physiomesh is a sterile, low-profile, flexible composite mesh designed to repair hernias and other fascial deficiencies. It contains polypropylene material with an absorbable film coating on each side.

2. How do I know if I received Physiomesh during my hernia surgery?

Your surgical records should indicate the type of mesh used during your procedure. Your attorney can help you obtain and review these records.

3. What compensation can be sought in a Physiomesh Lawsuit?

Victims can seek compensation for medical expenses, lost wages, pain and suffering, and other related damages resulting from the defective product.

4. How do I determine if I have a valid Physiomesh Lawsuit?

Consult with a legal professional to evaluate your case, including medical records, evidence of complications, and the connection to the Physiomesh implant.

5. What should I do if I suspect complications from a Physiomesh implant?

Seek medical attention immediately, document your symptoms and medical treatments, and consult with a lawyer to discuss your legal options.

6. Has Physiomesh been recalled?

Ethicon voluntarily withdrew Physiomesh from the global market in May 2016 due to higher than average recurrence and reoperation rates.

7. How long do I have to file a Physiomesh lawsuit?

The statute of limitations varies by state, but generally ranges from 1-6 years from the date of injury or discovery of injury.

8. Are there any class action lawsuits for Physiomesh?

There is a class action lawsuit in Canada, and in the United States, many Physiomesh cases have been consolidated into multidistrict litigation (MDL).

9. What other hernia mesh products are involved in lawsuits?

Other hernia mesh products involved in litigation include Atrium C-QUR, various Bard/Davol meshes like Composix, and Gore Medical hernia mesh products.

See the other medical device lawsuits our lawyers have covered.

Gore Medical Hernia Mesh

In addition to Physiomesh and the Atrium C-QUR hernia mesh lawsuit, our lawyers are filing lawsuits for people who were injured by mesh products made by Gore Medical. These include:

  • Gore-Tex Soft Tissue Patch
  • Gore Bio-A Hernia Plug
  • Gore Dualmesh Biomaterial
  • Gore Dualmesh Plus Material
  • Gore Synecor Intraperitoneal Biomaterial
  • Gore Synecor Preperitoneal Biomaterial

Time is limited to pursue legal action for Physiomesh injuries. Most states have a statute of limitations that restricts the time you have to file a claim, often just 2-3 years from the date of injury or when you discovered your injury was related to Physiomesh.

At Schmidt & Clark, LLP, we offer:

  • Free, confidential case evaluations with no obligation
  • No upfront costs or attorney fees
  • Payment only if we secure compensation for you

Don’t delay seeking the justice and compensation you deserve for your Physiomesh injuries.

Do I Have a Physiomesh Lawsuit?

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in physio mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by an Ethicon Physiomesh composite mesh hernia patch, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.

References:

[1] https://www.medtechdive.com/news/jj-hernia-mesh-settlement-prompts-judge-to-dismiss-more-than-200-cases/701668/ 

[2] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm 

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