Surgical mesh devices have been in use since the 1950s. They were originally developed for the support of the abdominal wall in the course of hernia surgery. In the 1990s, the mesh products began to be utilized in the repair of pelvic organ prolapse (POP).
Unfortunately, both the hernia mesh and the POP mesh have been associated with numerous complications.
The History of the Hernia Mesh
Surgeons started employing polyethylene in the repair of inguinal hernias in the 1940s. The first use of a polyethylene fiber mesh for this type of surgery was first described in 1959. This product was the Marlex Mesh, which according to a 1967 article published in the Archives of Surgery, was “well tolerated by the tissues, even in the presence of infection.”
That conclusion was based on the author's own experience performing 70 hernia repairs with the polyethylene Marlex mesh over seven years. By the time that article was published, however, physicians had switched to a polypropylene mesh. This material was more pliable and had a higher melting point, allowing for sterilization in an autoclave (the earlier polyethylene type had to be boiled or cold-sterilized with alcohol).
By 1987, Dr. Irving Lichtenstein, one of the innovators in the treatment and surgical repair of hernias, published a study that tracked over 6300 hernia patients who had undergone surgery with the polypropylene mesh over 2 to 14 years. The recurrence rate among these patients was less than 1%.
Since then, the “Lichtenstein Repair,” which Dr. Lichtenstein described as “tension free,” has become the most common surgical treatment for an inguinal hernia. The advantage of this method is that it does not put tension on the muscles surrounding the injury, unlike suture repairs such us the Bassini and Shouldice techniques. It also requires far less patient recovery time.
Laparoscopic (non-invasive) inguinal hernia surgery was first described in 1979. However, it was not until ten years later that such surgery was first attempted with the use of a mesh. In 1998 a study of over 10,000 laparoscopic hernia patients over an average of three years found a recurrence rate of only 0.4 percent.
Mesh Medical Device Complications Become Apparent
In 2002, the FDA gave its approval to the transvaginal mesh for use in the treatment of POP and stress urinary incontinence (SUI). At the time, manufacturers claimed that complications were rare. However, over the next several years, the FDA began receiving a growing number of adverse event reports. Between 2008 and 2010, there were 1500 reports of severe complications related to the transvaginal mesh, including seven deaths – three of which were directly related to the mesh.
Despite this information and growing litigation over the transvaginal mesh, medical device manufacturers continued to market and promote mesh products for the surgical treatment of hernias. In 2016, synthetic hernia mesh products accounted for over two-thirds of global sales, with manufacturers touting their low cost and “incredible clinical acceptance” by the medical community and government health agencies. In its quest for increased revenues and profits, the industry began marketing their products for unnecessary purposes, such as minor hernias that might be better repaired with sutures.
By the end of 2016, the FDA had received reports of ten fatalities associated with just one mesh device, which had been approved six years earlier through the questionable 510(k) Pre-market Clearance process. That product, the Ethicon Physiomesh, wound up being implanted in approximately 300,000 patients before the manufacturer issued a recall. The company's “urgent” Field Safety Notice stated that “recurrence/reoperation rates…...were higher than the average rates of the comparator set of meshes among patients,” adding that there was likely a number of causes for the failures (including “operative and patient factors”).
Hernia Mesh Defective Design
The polypropylene Ethicon Physiomesh was coated with an absorbable film coating, which the manufacturer claimed made it easier to implant into the patient's tissues, thus reducing the risk of inflammation.
Instead, the film coating has caused an increase in the rate of infections. Lawsuits claim that:
“...the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma [fluid buildup and swelling] formation, and which in turn can cause infection, abscess formation and other complications…[providing] a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”
The Physiomesh is only one such “composite mesh” that includes a coating. Manufacturers have claimed that such coatings serve as a “barrier.” However, because these companies agreed they would not market their hernia mesh devices as a “barrier,” they were able to bypass the clinical studies normally required by the FDA. As a result, there is virtually no reliable data on these devices, and there has been an abnormally high rate of complications associated with these coated hernia mesh products.
Hernia Mesh Injuries and Symptoms
In addition to causing serious infections, the hernia mesh can migrate (fall out of place) or shrink. This can result in:
- bowel perforation
- organ damage
- adhesion (the mesh becomes embedded in the bowel) and resultant obstruction
- nerve damage
- sexual dysfunction (when the hernia repair involves the spermatic cord)
- dental problems
- neurological changes
- renal failure (when the coating is absorbed into the bloodstream)
- liver injury
- joint pain
- autoimmune disorders
Symptoms of hernia mesh-related injury can include:
- unusual pain in the abdomen, legs, groin, testicles and/or joints
- diarrhea or constipation (due to bowel obstruction)
- pain during sex
- frequent headaches
- excessive, unusual sweating
These complications virtually always necessitate removal of the mesh. Unfortunately, this is difficult to do when the mesh has eroded into the surrounding tissues, and in some cases, it is impossible.
Hernia Mesh Lawsuits
Thousands of claims have been filed against the manufacturers of hernia mesh medical devices, alleging that the products fail at a rate higher than expected, and then cause additional surgeries, infections, bowel obstruction, organ damage, scar tissue and chronic pain.
The manufacturers being named in the complaints include:
- American Medical Systems
- Boston Scientific
- C.R. Bard/DaVol
For extensive information on these claims, visit our Hernia Mesh Lawsuit Page. This page describes in detail the litigation pending against the various manufacturers, and how someone injured by a Hernia Mesh can participate in the court proceedings and receive compensation for their injuries.