Physiomesh Hernia Mesh Lawsuits
Many individuals have been suffering after undergoing laparoscopic hernia repair surgery where Physiomesh composite mesh has been installed. As a matter of fact, patients around the country have been coming forward needing revision surgery because of the serious complications linked to Physiomesh.
In lawsuits filed, the Johnson & Johnson subsidiary, Ethicon, has been alleged to be aware of the risks associated with the devices but nevertheless allowed distribution of the hernia mesh that have been implanted in many now suffering patients.
In a newly filed lawsuit, it is alleged that Ethicon and Johnson & Johnson were aware that the implanted Physiomesh hernia device would cause harm yet knowingly misrepresented facts about the dangers to the Federal Food and Drug Administration (FDA).
Hernias are common place which develop when fatty tissue or a part of the bowel squeezes or protrudes through a hole or weak section tissue most commonly in the abdominal wall.
The most common types of hernias are:
- Incisional which occurs through scar tissue or a surgical incision in the abdomen;
- Inguinal which is located in the groin area; and
- Femoral which generally arises in a person’s thigh or outer groin area.
Most of the hernia operations in the U.S. are to repair inguinal hernias. More than one million hernia repairs of all kinds have been reported to have been completed in the last 12 months in the U.S.
Many of the surgical procedures that repair hernias include laparoscopic surgeries where small incisions are made in the abdomen or other perhaps the more complicated surgeries where the incision is made near the hernia and is made as an open repair to fix the weak muscle. The Ethicon Physiomesh composite mesh is used by physicians and surgeons to strengthen and support the hernia site. Most of the mesh devices are made from synthetic materials like polypropylene, a kind of plastic.
The complications reported by the Federal Drug Administration with respect to the Ethicon Physiomesh are chronic pain, infection, hernia revisions, hernia recurrence, adhesions and scar tissues, blockage of the large or small intestine, continued bleeding, surgery and fluid build-up.
In some cases, the mesh itself migrates or shrinks.
Physiomesh is used in most cases to repair ventral hernias. These hernias occur when the body’s internal organs squeeze through an opening or weak spot at the site of a previous surgical incision. Ventral hernias can happen soon after a surgery or months and sometimes even years later. Smaller ventral hernias can be repaired with a fairly non-invasive surgical procedure that may require an incision and just a few stitches in the repair. But a large or complex hernia will necessitate reconstructive surgery on the abdominal wall. The complex surgery will require a much longer recovery time for the patient.
In any given year and most recently, surgeons have performed anywhere from 100,000 to 150,000 ventral hernia surgeries in the United States. The less invasive surgeries are laparoscopic, whereas the more complicated surgeries are done by opening the abdomen. The most common ventral hernia repair surgery will have the surgeon stitch a mesh patch over the hernia to give strength to the abdominal wall. Hernia mesh will also be used to reinforce the abdominal wall. This will in most situations prevent the hernia from re-opening. A re-opening is referred to as a recurrence. The issue here is that some mesh types are better and more durable which their intended purpose is. Some mesh products are less likely to cause a recurrence. Naturally patients who go through the rigors of a surgery to repair an abdominal wall are not expecting that the mesh and the procedure will fail.
In May 2016 Ethicon, Inc. and Johnson & Johnson notified patients and physicians and hospitals that the company had made a voluntary product recall of Ethicon Physiomesh Flexible Composite Mesh because of the recurrence of problems after a laparoscopic ventral hernia repair. Two studies found that the Physiomesh Composite Mesh had higher rates of hernias re-opening requiring additional surgeries. The studies were critical of the Physiomesh product because it compared poorly next to other mesh products. There was a known increased risk of side effects when the mesh was implanted. In two comprehensive studies done in Germany and Denmark, they concluded that higher rates of hernia recurrence and re-operation of Physiomesh was confirmed when compared to other similar products that were used in laparoscopic ventral hernia repair surgeries. This was according to an Urgent Field Safety Notice (PDF) to surgeons.
The Physiomesh hernia patch is made from polypropylene filaments which are non-absorbable, flexible plastic. The plastic is woven into a fabric that makes up the mesh. The mesh patch is laminated with layers of Monocryl or poliglecaprone, which are intended to have anti-inflammatory and/or anti-adhesion properties that are considered beneficial.
Physiomesh has been sold throughout the United States since March 2010. Because the Physiomesh was considered to be similar to other accepted mesh products at the time, the Federal Food & Drug Administration (FDA) of the United States Department of Health and Human Services approved the distribution and use of this mesh with what is called a 510 (k) application. This allowed Physiomesh to be marketed and sold for implanting without new safety studies because of its similarities to other types of hernia mesh that were on the market then.
Physiomesh has a different kind of coating that does other mesh products. The Physiomesh is coated which layers, which in recently filed lawsuits claim is not bio-compatible and often times sets off major health complications to patients who have had this mesh implanted. In one pending lawsuit the patient needed revision surgery because the coating on Physiomesh “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
In another lawsuit filed in September 2016, this patient required additional surgery to take out the Physiomesh that had grown into her intestines and caused her serious health problems.
In a lawsuit pending in the Southern District of Illinois, the patient was diagnosed with an infection around the Physiomesh that caused two abscesses and an intestinal fistula. In this case the patient needed surgery to remove the mesh and now has several serious health problems. That case has a trial date in January 2018. The United States District Court for the Southern District of Illinois is located in East St. Louis, Illinois.
The criteria for handling successfully a lawsuit involving the implanted Physiomesh are:
- The surgery was done laparoscopically.
- The Physiomesh was implanted between October 2010 and June 2016.
- The patient should be under a physician’s care now for hernia mesh removal or had a hernia mesh removal surgery.
If you or a family member has been injured or died by the Ethicon (Johnson & Johnson) Physiomesh Composite Mesh, Kreisman Law Offices is prepared to handle your case. Robert Kreisman has more than 40 years of experience handling product liability lawsuits, pharmaceutical device cases, pharmaceutical defect cases and medical device cases like hernia mesh devices.
With our years of experience in trying and settling medical product defect cases, Kreisman Law Offices provides the best possible services to our clients and have achieved unsurpassed results. Our service is unmatched. Please call us 24 hours a day at 312-346-0045 or toll free 800-583-8002 for a free and immediate consultation or complete a contact form online on our website.