Ethicon Physiomesh Lawsuit Info; Ethicon Initiates Voluntarily Withdrawal Of Physiomesh Hernia Product

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The FDA Received Reports That Use Of Surgical Mesh For Hernia Repair Can Cause Complications Such As Intestinal Blockage, Bleeding, Hernia Recurrence, And Infection.

physiomesh-lawsuit-hernia-mesh-lawsuit-ethicon-lawyer-attorneyEthicon Physiomesh lawsuit information: Ethicon has voluntarily removed its Physiomesh Flexible Composite Mesh from the global market after an analysis found minimally invasive ventral hernia repairs that use the product have higher rates of hernia recurrence and additional surgery compared to similar hernia mesh devices. Ethicon, a wholly-own subsidiary of Johnson & Johnson, advised health care professionals of its intentions through an Urgent Field Safety Notice in May. Ethicon’s action does not include a market withdrawal of its Physiometh Open Flexible Composite Mesh Device or other hernia mesh products made or sold by the company.
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon, May 25, 2016]

“Studies show that patients are placed at a higher risk for complications when the hernia mesh is used,” says Wright & Schulte LLC, a nationwide law firm which represents individuals injured by medical devices.

investigating Ethicon Physiomesh lawsuits and legal claims surrounding hernia mesh injuries

The attorneys at Wright & Schulte LLC are investigating Ethicon Physiomesh lawsuits and legal claims surrounding personal injuries from the Ethicon Physiomesh Flexible Composite Mesh. If you believe you or a loved one have experienced a recurrence of the hernia or had additional surgeries due to the Ethicon Physiomesh Flexible Composite Mesh or other surgical mesh medical devices, contact Wright & Schulte LLC for a free Ethicon Physiomesh lawsuit or Ethicon hernia mesh lawsuit consultation by calling 1-800-399-0795 or you can visit yourlegalhelp.com for more information.

Physiomesh Flexible Composite Mesh has higher rate of recurrence/reoperation compared to rates of similar products

According to Ethicon, an analysis of unpublished data from two large independent registries in Germany and Denmark has found that laparoscopic ventral hernia repair using its Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients in these registries. In an Urgent Field Safety Notice to health care professionals, Ethicon said it believes the higher rates are due to multiple factors, including “possible product characteristics, operative and patient factors, but the “increased rate cannot be fully determined at this time.” As a result, Ethicon said that it has not been 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]

Ethicon Physiomesh Flexible Composite Mesh is a sterile, flexible composite mesh used to repair hernias and other fascial defects in the abdominal wall that cause hernias. Ethicon’s hernia mesh received 510(k) clearance by the U.S. Food and Drug Administration (FDA) in 2010. Under the federal agency’s 510(k) process, manufacturers are not required to conduct human clinical trials of a medical device before it is launched on the market if they can prove that their products are substantially equivalent to a medical device already on the market. Ethicon reported at the time that its Physiomesh was substantially equivalent to its Proceed surgical mesh which is used to repair existing hernias and prevent new hernias. According to the FDA, there has been an increase in hernia mesh surgical repairs since the 1980s. However, surgical mesh can cause complications including pain, infection, hernia recurrence, and fistulas (abnormal connection between organs, vessels or intestines).
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 2010]
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/, FDA, January 26, 2016]

Over 33,000 other mesh lawsuits due to injuries

In addition to hernia repair mesh, Ethicon also offers tranvaginal mesh medical devices that are used to treat stress urinary incontinence and pelvic organ prolapse in women. Currently, court documents show that Ethicon is facing over 33,000 vaginal mesh lawsuit claims in the U.S. District Court, Southern District of West Virginia. The complaints allege that Ethicon’s bladder mesh products are defectively designed and can cause serious injuries including urinary problems, vaginal scarring, infection, organ perforation, and chronic nerve damage.

About Wright & Schulte LLC And Filing An Ethicon Physiomesh 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. Every day, 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 lawsuit or Ethicon hernia mesh lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.

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