In 2016, the manufacturers of Physiomesh, Ethicon, issued an urgent safety notice over complications related to the use of its product. The Johnson & Johnson subsidiary advised health practitioners worldwide to stop using the flexible composite mesh for the surgical repair of hernias.
WHAT IS PHYSIOMESH?
Physiomesh is a flexible surgical mesh manufactured by Ethicon. It is made of polypropylene and was manufactured for use to repair abdominal hernias. The mesh is implanted surgically to stabilize the stretched or weak tissue, preventing the hernia from bulging.
Phyisiomesh was approved for use in hernia repair by the FDA in 2010. The approval from the FDA was issued through the institution’s fast track 510(k) approval program. This only required Ethicon to prove that Physiomesh was safer for use than other similar products currently in the market.
WARNING FROM ETHICON
Despite being approved for use by the FDA, Physiomesh has been linked to various complications. In May 2016, Ethicon issued what they termed as a ‘voluntary product recall’. This notice from the company warned health practitioners worldwide against using the surgical mesh.
The product recall was the result of the analysis of data that showed a high recurrence of reoperation rates following the use of Physiomesh in laparoscopic hernia repair. According to the research, the average rates were much higher than other similar products in the market. Ethicon advised hospitals and health practitioners to stop the use of the Physiomesh and return them to the company for reimbursement.
ETHICON PHYSIOMESH LAWSUITS
Several lawsuits have been and continue to be filed against Ethicon over complications resulting from the use of the mesh in hernia repair. Patients have reported the following complications:
- Migration of the mesh
- Shrinking of the mesh
- Redness and swelling
- Formation of internal scar tissue
- Distortion of the mesh
- Recurrence of the hernia
- Damage to organs
- Damage to nerves
- Revision of surgery
- Build up fluid (seromas)
Patients filing lawsuits against Ethicon claim that the material used to manufacture Physiomesh is incompatible with human tissue, therefore promoting immune responses when it is implanted. This is contrary to Ethicon’s marketing the mesh as being manufactured using inert materials.
In addition to this, Physiomesh was further marketed as a means to not only prevent inflammation but also minimize adhesion. According to Ethicon, the mesh would be easily incorporated into the body. However, patients have reported inflammatory reactions that often result in damage to the tissue surrounding the mesh, migration of the mesh, improper healing as well as formation of scar tissue.
If you or a loved one was injured by Ethicon’s Physiomesh or any defective medical device, please contact the attorneys at Wood Law Firm LLP. Please, do not wait until it is too late to take legal action. Call us today at (806) 304-0447 or contact us now to schedule your free consultation.