Ethicon Hernia Mesh Lawsuits Expected After Ethicon, Inc. Market Withdrawal of Physiomesh Flexible Composite Mesh after Data Suggests Risk of Hernia Recurrence Is High
Southern Med Law, a law firm that represents the victims of defective medical devices, is now evaluating Ethicon hernia mesh lawsuits involving Ethicon, Inc.’s market withdrawal of Physiomesh Flexible Composite Mesh. Ethicon, a subsidiary of Johnson & Johnson, announced the Physiomesh market withdrawal via an Urgent Field Safety Notice issued to surgeons in May 2016. According to the company, unpublished data from two large independent hernia registries in Germany and Denmark suggested that this product was associated with higher rates of hernia recurrence and re-operation compared to similar products that are used in laparoscopic ventral hernia repair.
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon, May 2016]
“Physiomesh patients who believe they have experienced hernia recurrence following laparoscopic ventral hernia repair with this hernia mesh device may be entitled to compensation from Ethicon, Inc. We are offering free legal reviews to anyone who may have incurred medical bills, lost wages, pain and suffering, and other damages that could be related to the Ethicon’s market withdrawal of hernia mesh,” said Dr. François Blaudeau, the founder of Southern Med Law. For more information on hernia mesh lawsuits and to speak with an attorney call 1-205-547-5525 or visit www.southernmedlaw.com for further information or to fill out a contact form.
Physiomesh Flexible Composite Mesh is made from flexible, non-absorbable polypropylene filaments that are woven into a fabric and laminated. It is used to repair ventral hernias, which can occur at the site of a previous surgical incision. Ethicon brought Physiomesh to market in 2010, following the U.S. Food & Drug Administration’s 510(k) clearance protocols. This process does not require a device manufacturer to conduct human clinical trials of a new product when it is shown to be “substantially equivalent” to another device that was previously approved by the agency.
The Ethicon hernia market withdrawal involves all unexpired product codes of Physiomesh Flexible Composite Mesh and all unexpired Procedure Packs containing the product. The action does not involve any other Ethicon meshes, including another product called Physiomesh Open flexible composite mesh. Ethicon has advised physicians to “follow any patients treated with the pulled hernia mesh in the usual manner”.
[accessdata.fda.gov/cdrh_docs/pdf9/k093932.pdf, FDA, April 2010]
According to Ethicon, “the high revision rates associated with the market withdrawal of Physiomesh appear to be due to multifactorial issue,” possibly including “product characteristics, operative and patient factors.” At this time, the company said it is unable to issue further instructions to surgeons that might lead to a reduction in the recurrence rate. The company will not be returning Physiomesh Flexible Composite Mesh to the worldwide market.
As both an attorney and practicing obstetrician/ gynecologist with a specialization in advanced gynecological surgery, Dr. Blaudeau possesses a unique understanding of the factors involved in all manner of medical device lawsuits, including those that could potentially stem from Ethicon’s voluntary market withdrawal of Physiomesh. If you or a loved one believe you have experienced complications that may be related to hernia mesh, please contact Southern Med Law today to learn more about your legal rights. You can arrange for at 205-547-5525.
About Southern Med Law and Filing A Hernia Mesh 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 the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or someone you care about were harmed by Physiomesh Flexible Composite Mesh, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation hernia mesh lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203