Physiomesh Lawsuit Filings Allege Ethicon’s Hernia Mesh Causes Bowel Obstruction, Pain, Infection, Hernia Recurrence, And Other Complications
As federal Physiomesh Lawsuit filings continue against Ethicon Inc. over its Physiomesh Flexible Composite Mesh, a Danish study suggests the risk of using surgical mesh for hernia repair outweigh the benefits due to long-term complications from the device. Complications alleged in hernia mesh lawsuits over Physiomesh hernia mesh, include pain, infection, bowel perforation and revision surgery to remove the device. Ethicon voluntarily withdrew it’s hernia mesh from the market last year,
The hernia mesh study, published in the Journal of the American Medical Association, was based on data from the Danish National Patient Registry of 3,242 patients who had elective incisional hernia repairs in Denmark from January 1, 2007, to December 31, 2010. The study focused on hernia repair using mesh performed by either open or laparoscopic procedures compared to open repair without using mesh. Patients who had open mesh repair were followed for 59 months, those who had non-mesh open repair were followed for 62 months, and patients who had laparoscopic mesh repair were followed for 61 months. The need for recurrent hernia repair was lower for patients with open mesh and laparoscopic mesh repair. However, after five years of follow-up, researchers discovered 5.6 percent of patients who underwent open mesh hernia repair and 3.7 percent of patients who underwent laparoscopic mesh repair had complications that required surgery. The repair-related complication rate for patients with non-mesh repair was 0.8 percent, the study found.
“This study shows patients have complications with hernia repair using mesh and the men and women we have spoken to who had hernia repair in which Ethicon’s Physiomesh was used had similar complications,” says Dr. François Blaudeau, founder of Southern Med Law.
As both an attorney and practicing obstetrician/ gynecologist, 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 its Physiomesh Flexible Composite Mesh. The firm continues to offer no-obligation legal reviews on cases of hernia mesh failure. Patients who believe they have suffered serious hernia mesh injuries may be entitled to compensation from Ethicon. To speak with one of the firm’s attorneys regarding Ethicon Physiomesh lawsuits you can call 1-205-547-5525 or visit www.southernmedlaw.com for further information or to fill out an online contact form.
Physiomesh Flexible Composite Mesh 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 (FDA) 510(k) clearance protocols. This process does not require a manufacturer to conduct human clinical trials of a new medical device when it is shown to be “substantially equivalent” to another device that was previously approved by the FDA. However, in May, Ethicon voluntarily withdrew its hernia mesh after reviewing unpublished data from two large independent hernia registries in Germany and Denmark that suggested the hernia mesh was associated with higher rates of hernia recurrence and re-operation compared to similar products used in laparoscopic ventral hernia repair.
Court documents show that Ethicon hernia mesh lawsuits allege the Flexible Composite Mesh is defective and unreasonably dangerous and causes chronic abdominal pain, infection and other complications. The complaints further allege Ethicon did not warn about the risks associated with using its mesh.
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