Physiomesh Lawsuit – Hernia Complications

Ethicon physiomesh lawsuitEthicon Physiomesh Flexible Composite surgical mesh has been shown to have a higher-than-normal rate of hernia recurrence and reoperation. Johnson & Johnson, parent company of Ethicon withdrew the surgical mesh in May of 2016 but it may be responsible for many injuries and the company may be facing multiple lawsuits by people who were harmed.

The first few of what may be multiple lawsuits have already been filed against surgical mesh manufacturer, Ethicon, a subsidiary of the medical products giant, Johnson & Johnson. It’s product, Ethicon Physiomesh Flexible Composite surgical mesh was found to have a high rate of hernia recurrence and reoperation. The product was voluntarily withdrawn from the U.S. market in May of 2016 but thousands of patients may have received Ethicon Physiomesh as part of a hernia repair and may have been placed at risk for injury.

About Ethicon

Ethicon manufactures a number of medical products used in surgical procedures. The company was started in 1887 as a manufacturer of wound closure and suture devices and by World War II, was manufacturing about 70% of the world’s surgical sutures. It was acquired by Johnson & Johnson in 1947 and now holds a majority of the U.S. market in wound tissue management.

One of the major products of Ethicon is its line of surgical mesh products. These are used in a number of surgical repair procedures to stabilize tissue and while many patients have been helped, Ethicon surgical mesh has a long history of problems including thousands of lawsuits filed for its transvaginal mesh.

Ethicon Physiomesh Flexible Composite surgical mesh was introduced to the U.S. market in 2010 for use in abdominal surgeries, specifically, hernia repair and is implanted laparoscopically. It was approved by the U.S. Food and Drug Administration under a “shortcut” pathway, known as the 510(k) premarket authorization. The 510(k) pathway allows a manufacturer to avoid costly clinical studies by claiming it’s similarity to other products already on the market. Many products approved using this process were never tested in humans before being introduced to the market as a whole.

Ethicon Physiomesh Withdrawal

Ethicon withdrew its Physiomesh products in May 2016 after an unusually high rate of hernia recurrence and reoperation was seen in patient who received the product. This was confirmed by analysis of two separate registries which track hernia procedures. The Herniamed German Registry and Danish Hernia Database both showed a higher-than-expected rate of recurrence and reoperations in patients who received Ethicon Physiomesh vs. other products.

The May 2016 withdrawal affecting all lot number of Ethicon Physiomesh Flexible Composite was announced by the company and a safety announcement was issued by the FDA. The safety alert and withdrawal instructed physicians and surgical facilities to remove all Physiomesh inventory from active practice and return all units to the company.

Unfortunately, many patients had already been harmed by the surgical mesh and many more may still be at risk.

Ethicon’s Physiomesh is constructed of an artificial plastic, polypropylene, which was intended to minimize inflammation. Unfortunately, it appears that it may do the opposite in some patients, doing more harm than good.

Complications that may be caused by failure of the mesh to function as intended may include:

  • Severe pain
  • Abdominal swelling
  • Bowel obstruction
  • Bowel adhesion
  • Mesh migration
  • Bacterial infection
  • Organ obstruction
  • Hernia recurrence
  • Reoperation requirement

Ethicon Physiomesh Lawsuits

Several lawsuits have already been filed against Ethicon for injuries caused by its Physiomesh and many more may be expected. Lawsuits already pending include:

  • A September 2016 lawsuit filed in U.S. District Court for the Middle District of Florida, Orlando Division, filed by a woman who received the mesh in 2014 and experienced a recurrence of her injury in 2015, requiring additional surgery.
  • A November 2016 lawsuit filed in U.S. District Court in Massachusetts by a man who received Ethicon Physiomesh as part of a laparoscopic repair in 2013 and required a second surgery later the same year and again in 2016.
  • A lawsuit filed in the U.S. District Court of Illinois by a man who received the mesh for hernia repair in 2013 and required reoperation in 2015.

Patients who undergo hernia repair experience significant pain and recovery time and a second procedure may be more serious. Recurrence of a previously repaired hernia can be much more painful and reoperation procedures may be more difficult, require longer in-operation time, put the patient at additional risk for infection and complications and pose the problem of a lengthy recovery period.

Patients who have experienced complications after receiving Ethicon Physiomesh may be eligible for compensation if Ethicon Physiomesh Flexible Composite was:

  • Implanted between March 1, 2010 to May 31, 2016
  • Implanted laparoscopically
  • Implanted to treat a ventral or abdominal hernia

Compensation for medical injuries caused by defective medical devices may include coverage of medical costs, lost wages, pain and suffering and future medical needs. Each case is unique and must be considered separately but patients or loved ones of those who have experienced medical injury after receiving Ethicon Physiomesh Composite should seek legal advice.

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