Ethicon Inc. Issues market withdrawal of Hernia Mesh After Patients Need Revision Surgery And Have Recurrence Of Hernia.
Ethicon Inc. has issued a market withdrawal of its Physiomesh Flexible Composite Mesh from the United States. The withdrawal of their repair mesh comes after studies showed a higher rate of revision surgeries and hernia recurrence associated with the product. As the Johnson & Johnson subsidiary handles the current withrawal of theirf hernia mesh, Ethicon is currently defending itself against 32,000 vaginal mesh lawsuits. These mesh lawsuits involve Ethicon’s transvaginal mesh that plaintiffs say causes nerve damage, chronic pelvic pain, and punctures of internal organs. (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, May 2016]
According to Ethicon’s May 25 letter to doctors and hospitals, Ethicon withdrew the hernia mesh from the market based on two large independent hernia registries. The letter was issued to operating room supervisors, materials management personnel, and chiefs of surgery. The Herniamed German and Danish Hernia Database-DHDB Registries showed the recurrence and reoperation rates after a minimally invasive ventral hernia repair using Physiomesh. The hernia mesh surgery revision rates were higher than the average rates of comparable meshes among patients in these registries.
Southern Med Law is currently offering legal evaluations of Ethicon’s Physiomesh Flexible Composite Mesh. If you believe you have been injured by hernia mesh contact one of the firm’s attorneys for a free legal consultation by calling 205-547-5525 or visit www.southernmedlaw.com for more information and to fill out the online contact form.
Ethicon Hernia Mesh Revision Rates
Ethicon believes the higher hernia mesh revision rates involve many factors, such as “possible product characteristics, operative and patient factors” but the company has not been able to “fully characterize these factors.” Since the company has not been able “to issue further instructions to surgeons that might lead to a reduction in the recurrence rate,” Ethicon decided to issue a withdrawal for the hernia repair mesh, the letter said. Ethicon does not plan to put the Physiomesh Flexible Composite Mesh back on the global market. The withdrawal does not include the Ethicon Physiometh Open Flexible Composite Mesh Device or other hernia mesh devices made or sold by the company.
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon Inc., May 25, 2016]
What is Ethicon Physiomesh Hernia Mesh?
Ethicon’s Physiomesh is a sterile, flexible composite mesh used to repair hernias and other fascial deficiencies. The Physiomesh was cleared in 2010 under the U.S. Food and Drug Administration’s (FDA) 510k process, also known as the “fast track program by news organizations and politicians.” The 510k process does not require medical devices to be tested on humans if the products are determined to be substantially equivalent to another legally marketed device. Ethicon had reported its Physiomesh was substantially equivalent to its Proceed surgical mesh. The Proceed mesh was also designed to repair existing hernias and prevent new hernias. In 2005, Ethicon issued a hernia mesh recall for Proceed due to the layers separating and exposing the underlying polypropylene mesh which could result in patients having adhesions and fistulas. Ethicon’s Proceed mesh was later returned to the market.
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 9, 2010]
[surgicalproductsmag.com/article/2012/02/discussing-mesh, February 1, 2012]
Ethicon Hernia Mesh Lawsuits
While men and women nationwide filed Proceed hernia mesh lawsuits the company is also facing 32,000 vaginal mesh lawsuits. Women from around the country allege Ethicon’s transvaginal mesh products are defectively designed and can cause serious injuries. The alleged defective bladder mesh has caused women to suffer such injuries as infection, vaginal scarring, organ perforation, urinary problems and chronic nerve damage.
About Southern Med Law And Filing An Ethicon Physiomesh Hernia Mesh Lawsuit
Southern Med Law is led by attorney Dr. François Blaudeau who is also a practicing obstetrician/gynecologist. Dr. Blaudeau is determined to stop large manufacturers of personal health products and medical devices from injuring more people. The legal staff at Southern Med Law is an experienced group of attorneys who have successfully taken on Ethicon in many defect medical device lawsuits. The attorney possess a deep understanding of the complex medical and legal questions involved in product liability and personal injury claims. They are committed to ensuring that all victims have access to the type of aggressive legal representation that assures success.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
Medical Negligence/MedicalDevice/Pharma/Qui Tam