If you or a loved one had complications or suffered a hernia recurrence in the time period after a hernia repair procedure, there is help for you and your family. Ethicon®, a subsidiary of Johnson & Johnson®, has voluntarily withdrawn from the market, a commonly used hernia repair product, called Physiomesh® Flexible Composite Mesh. Ethicon voluntarily pulled Physiomesh® off the market in May 2016 due to studies showing Physiomesh® had alarmingly high-rates of complications, hernia recurrences and revision surgeries in patients.
Medical professionals had until September 16, 2016, to return unused Physiomesh, hernia mesh, for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson. Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes. The mesh was used in laparoscopic and ventral and inguinal hernia repair surgeries. The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.
What is Physiomesh?
Physiomesh is hernia patch that is made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into a fabric. The patch is laminated between two layers of Monocryl (poliglecaprone), which is intended to have anti-inflammatory or anti-adhesion benefits.
Physiomesh has been on the market in the United States since March 2010. The FDA approved it with a 510(k) application, which allowed it on the market without new safety studies because it was “similar” to other types of hernia mesh on the market.
Why Was Physiomesh® Pulled Off The Market?
Recent studies and data clearly demonstrated increased complications and mesh failures with Physiomesh®, compared to other mesh products on the market. Ethicon® (the Johnson & Johnson® subsidiary that makes Physiomesh®) was alerted to the Physiomesh® problems from data provided by the HerniaMed German Registry and the Danish Hernia Database. Upon being alerted to these findings, Ethicon® released an “Urgent Field Safety Notice” to operating room supervisors and chiefs of surgery. This “Urgent Field Safety Notice” set forth an immediate product withdrawal for Physiomesh® stating, “EFFECTIVE IMMEDIATELY – DO NOT USE OR DISTRIBUTE Ethicon® PHYSIOMESH®.”
If you had surgery to repair a ventral or an inguinal hernia between the years of 2010 and 2016 your surgeon could have used Physiomesh®, as it was widely used before the voluntary product withdrawal. Your medical records would clearly state if your surgeon used Physiomesh® for your hernia repair. And due to the seriousness of the Physiomesh® withdrawal, you may have received (or will soon receive) a letter from your doctor stating the withdrawn mesh product was implanted during your surgery. But since doctors are not obligated to notify their patients, many doctors do not. In fact, most doctors probably won’t, so you need to find out for yourself and take your health into your own hands.
A number of lawsuits have already been filed. Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia. In July 2015, he developed severe abdominal pain, fever, chills, nausea, and redness. He was treated for an infection and two abscesses and an intestinal fistula. His case is set for January 22, 2018, in the Southern District of Illinois. Case No. 3:16-cv-00368.
Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility, and bowel obstruction. Here is an adverse event report submitted to the FDA that says the mesh pulled away from the abdominal wall resulting in a second surgery. In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT Secur and Prosima Pelvic Floor Repair System. The company said the removal was for business reasons.
You May Be Eligible For Financial Compensation Having Been Affected By A Defective Medical Device
Medical device manufacturers are subject to strict guidelines and rules by the FDA. The FDA puts rules in place that require medical device manufacturers to conduct extensive testing, research and clinical trials before their device can be used in hospitals. This is done so doctors and patients like yourself can weigh the benefits of using a particular medical device against the possible dangers and consequences it may pose. And it gives doctors the ability to make an informed decision about which brand of hernia mesh to use, based on available safety data gathered in pre-market testing and trials.
What to do if you think you’re eligible for a hernia mesh lawsuit?
If you have experienced hernia mesh pain symptoms, call Jones Brown Law today for a free consultation. Our experienced team of Defective Medical Device lawyers will guide you every step of the way through the legal process of getting the compensation you deserve.
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