Physiomesh Lawsuit | Physiomesh Failures, Complications, Problems

Physiomesh Lawsuit | Physiomesh Failures, Complications, Problems

Physiomesh Lawsuits | Physiomesh Failures, Physiomesh Voluntary Recall, Physiomesh Problems, Physiomesh Complications | Physiomesh Lawyer | Physiomesh Hernia Repair Lawsuit

physiomesh-lawsuit-physiomesh-failures-recall-complications-problems-lawyerPhysiomesh Lawsuit Information: The Ethicon Physiomesh Flexible Composite Mesh places patients at higher risk of revision surgeries and hernia recurrence, according to an analysis of the hernia repair product. As a result, Johnson & Johnson’s subsidiary Ethicon Inc. market withdrawal of Physiomesh in May 2016 and will no longer sell the product. In a letter to health care providers, Ethicon said it was not sure what was causing the Physiomesh failure problems. In addition to its hernia mesh, Ethicon has had problems with its transvaginal mesh products that treat stress urinary incontinence and pelvic organ prolapse in women. More than 32,000 transvaginal mesh lawsuits are pending that allege the devices cause complications including infection, organ perforation, chronic nerve damage, and chronic pain. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327)
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon Inc., May 25, 2016]

Ethicon Physiomesh Lawsuit Due to Physiomesh Failure Or Problems

Southern Med Law is now offering free, no-obligation Ethicon Physiomesh Lawsuit case reviews to individuals who have been injured by the hernia mesh Physiomesh failure as well as transvaginal mesh products that treat stress urinary incontinence and pelvic organ prolapse. To arrange for an Ethicon Physiomesh lawsuit review, please contact Dr. François Blaudeau and the legal staff at Southern Med Law filling out our online form, or by calling the office directly at 205-547-5525.

Studies Prompt Physiomesh Market Withdrawal Due to Problems / Failure

physiomesh-lawsuit-physiomesh-failures-recall-complications-problems-lawyerEthicon announced that the Physiomesh withdrawal was based on an analysis of unpublished data from the Herniamed German Registry and Danish Hernia Database-DHDB. The registry data showed the rates of hernia recurrence and revision surgeries after a minimally invasive ventral hernia repair using Ethicon Physiomesh Composite Mesh were higher than the average rates for the comparator set of meshes among patients. The company was not sure why the rates were higher but believes “possible product characteristics, operative and patient factors” may have played a role.
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon Inc., May 25, 2016]

What is Physiomesh flexible composite mesh?

physiomesh-lawsuit-physiomesh-failures-recall-complications-problems-lawyer2Physiomesh is a large pore, flexible composite mesh made of non-absorbable polypropylene and used in minimally invasive ventral hernia repair and other fascial deficiencies. A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. A ventral hernia is a bulge through an opening within the abdominal wall muscles. Synthetic mesh in hernia repair is preferred over using sutures because it reduces the risk of infection and pain, and provides quicker recovery time.
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 9, 2010]
[ncbi.nlm.nih.gov/pmc/articles/PMC3025220/, Annals, May 2010]

Physiomesh and Hernia Mesh Complications

According to the U.S. Food and Drug Administration (FDA), the most common adverse events reported for hernia repair surgery include:

  • Pain
  • Infection
  • Hernia recurrence
  • Scar-like tissue that sticks tissues together (adhesion)
  • Intestinal blockage
  • Bleeding
  • Perforation (a hole in neighboring tissues or organs)

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm, FDA, April 7, 2016]

What is Physiomesh flexible composite mesh?

Physiomesh is a large pore, flexible composite mesh made of non-absorbable polypropylene and used in minimally invasive ventral hernia repair and other fascial deficiencies. A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. A ventral hernia is a bulge through an opening within the abdominal wall muscles. Synthetic mesh in hernia repair is preferred over using sutures because it reduces the risk of infection and pain, and provides quicker recovery time.
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 9, 2010]
[ncbi.nlm.nih.gov/pmc/articles/PMC3025220/, Annals, May 2010]

The FDA and Physiomesh

Ethicon Physiomesh Flexible Composite Mesh received clearance from the FDA through the agency’s 510k process. This process does not require human testing if manufacturers of medical devices can prove that their products are substantially equivalent to another legally marketed device. In requesting approval, Ethicon said Physiomesh was substantially equivalent to its Proceed hernia mesh. However, Ethicon recalled its Proceed hernia mesh in 2006 because the layers separating and exposing the underlying polypropylene mesh during a hernia repair procedure could increase the risk of patients having adhesions and bowel fistulas. Proceed was later returned to market.
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 9, 2010]
[accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=43417&CREATE_DT=2006-01-26, FDA, June 13, 2016]

Ethicon Physiomesh Lawsuit Due to Physiomesh Failure Or Problems

Southern Med Law is now offering free, no-obligation Ethicon Physiomesh Lawsuit case reviews to individuals who have been injured by the hernia mesh Physiomesh failure as well as transvaginal mesh products that treat stress urinary incontinence and pelvic organ prolapse. To arrange for an Ethicon Physiomesh lawsuit review, please contact Dr. François Blaudeau and the legal staff at Southern Med Law filling out our online form, or by calling the office directly at 205-547-5525.

About Southern Med Law And Filing An Ethicon Physiomesh Lawsuit

Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to negligent pharmaceutical manufacturers. If you or a loved one have been injured by a Physiomesh Flexible Composite Mesh, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation Physiomesh lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.