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Ethicon Physiomesh Lawsuit 2017-10-15T23:31:15+00:00

The Ethicon Physiomesh Flexible Composite Mesh used in minimally invasive ventral hernia repair, has been withdrawn from the global market by Ethicon, a wholly-owned subsidiary of Johnson & Johnson. Ethicon initiated market withdrawal action after an analysis showed the hernia repair mesh places patients at higher rates of hernia recurrence and revision surgery. Ethicon said in an Urgent Field Safety Notice sent to health care providers in May 2016 that an analysis was conducted of unpublished data from two large independent hernia registries, the Herniamed German Registry and Danish Hernia Database. The data showed the recurrence and additional surgery rates after laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh were higher than the average rates of comparable meshes among patients in these registries. Ethicon said it was not sure why the rates were higher. The company also said in its safety notice that it was not able to issue further instructions to surgeons that might lead to a reduction in the recurrence rate.[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon, May 25, 2016] [accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 2010]

The Ethicon Physiomesh lawsuit attorneys at Wright & Schulte LLC are investigating legal claims of injuries due to the Ethicon Physiomesh Flexible Composite Mesh. If you or a loved one suffered serious injuries from Ethicon’s Physiomesh or other surgical mesh products, contact Wright & Schulte LLC for a free Ethicon Physiomesh hernia mesh lawsuit consultation by visiting yourlegalhelp.com.

Ethicon Physiomesh Flexible Composite Mesh

The Ethicon Physiomesh received clearance in 510(k) process from the U.S. Food and Drug Administration (FDA) in 2010. Under the FDA’s 510(k) process, medical device makers are not required to test their devices on humans if they can prove that the medical devices are substantially equivalent to a device already on the market.[fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/, FDA, January 26, 2016]

Hernias And Hernia Mesh Repairs

The FDA reports that more than 1 million hernia repairs are performed each year in the United States. There has been an increase in hernia mesh surgical repairs since the 1980s, according to the FDA. Surgical mesh is used to strengthen the hernia repair and reduce the rate of recurrence. Most hernias are caused by pressure and a weakness or opening of a muscle or connective tissue. The pressure pushes the tissue or an organ through the opening or weak spot, according to the FDA. A hernia is caused by anything that increases abdominal pressure, such as lifting heavy objects, obesity, diarrhea or constipation.[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm, FDA, April 7, 2016] [bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon, May 25, 2016]

Hernia Mesh Complications And Side Effects

The FDA notes that using surgical mesh for hernia repair can cause complications. The most common adverse events reported to the FDA for all surgical repair of hernias include:

  • Adhesion (scar-like tissue that sticks tissues together)
  • Bleeding
  • Fistula (abnormal connection between organs, vessels or intestines)
  • Hernia recurrence
  • Infection
  • Mesh migration
  • Mesh shrinkage
  • Obstruction (block of the large or small intestine)
  • Pain

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

Ethicon Transvaginal Mesh Lawsuits

In addition to its Physiomesh Flexible Composite Mesh, Ethicon is also dealing with issues involving its transvaginal mesh products used to treat stress urinary incontinence and pelvic organ prolapse in women. Court documents show that Ethicon is one of seven transvaginal mesh manufacturers involved in a multidistrict litigation in the U.S. District Court, District of West Virginia. Ethicon is defending itself against 33,000 lawsuits that allege its surgical mesh products cause complications including chronic pain, infection, organ perforation, and chronic nerve damage.
(Physiomesh Lawsuit Case No. In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327)

About Wright & Schulte LLC And Filing An Ethicon Physiomesh Lawsuit Or Ethicon Hernia Mesh Lawsuit

Wright & Schulte LLC, is an experienced personal injury firm and is dedicated to it’s clients and the belief that America’s legal system should work for the people. The attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure corporations take responsibility for their actions. If you are looking for a law firm that will guarantee the aggressive and personal representation you deserve, do not hesitate to contact Wright & Schulte LLC today. Free Ethicon Physiomesh hernia mesh lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.

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