Surgical mesh consists of a loosely woven sheet, made from both biological and artificial materials that have been used in a variety of corrective surgeries. Primarily, surgical mesh is employed for hernia repair and the treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Some of these surgical mesh devices are permanent; others are designed to dissolve over a period of time. In both cases, they have been associated with serious and debilitating complications due to inflammation, organ perforations, fistulas, and more. In extreme cases, mesh complications have resulted in the death of the patient.
Shockingly, approximately one patient in five can expect to experience complications from mesh repairs.
The history of surgical mesh in the repair of hernias dates back nearly 130 years, to 1890. It was in that year that German physician Theodor Billroth first suggested that a “prosthetic material” would be an effective way to close a hernia injury. Surgeons experimented with numerous materials, including silk and cotton, but virtually every surgery failed because of an infection or injury recurrence.
The modern surgical mesh appeared in the mid-1950s when one Dr. Francis Usher first developed a woven mesh made from a type of plastic known as polyolefin. Eventually, he realized that polypropylene was a better material. By the late 1980s, what has come to be known as the Lichtenstein, or Tension-Free Repair for hernia became one of the most frequently-employed surgical techniques.
One of the earliest hernia mesh products was the Composix Kugel Hernia Patch, designed and manufactured by C.R. Bard. Similar in appearance to an oval-shaped pad, the Composix mesh consisted of plastic fibers, supported by a metal “hoop,” known as a “memory recoil ring.” The idea was for the mesh to be folded for insertion into the surgical site. The “memory ring” would then spring back into its original shape.
The device was subject to an FDA recall in 2006 when it was discovered that the memory ring was fragile and prone to breakage. This led to patients experiencing bowel injuries and enteric fistula (an abnormal connection between the gastrointestinal system and the skin). The result was chronic, debilitating pain.
After this recall, Bard replaced the metal memory coil ring with one made from polyethylene terephthalate (PET), a type of plastic similar to polyester. In less than a year, the plastic memory ring was found to have the same problem.
Aside from breaking memory coil rings, the two materials from which the Composix was made had their own problems. One of these, polypropylene (commonly used in “living hinges” and plumbing systems), was thought to be ideal because of its resilience. However, it was proven to be incompatible with human tissues, causing chronic inflammation among other complications.
The other material was polytetrafluoroethylene (ePTFE), which is essentially a form of Teflon. These two materials degrade at different rates, causing the device to deform and ultimately breaking the ring. It could also result in the mesh falling out of place, increasing the risk of organ perforation.
In 2011, after losing a lawsuit to an injured plaintiff and ordered to pay a $1.5 million judgment the previous year, C.R. Bard settled more than 1,000 hernia mesh cases for $184 million.
Since then, other manufacturers, such as BD Medical Technology, Davol, Inc., and Johnson & Johnson’s Ethicon division have been targeted in lawsuits by patients who have been severely injured by surgical mesh devices – some of which were approved under 510(k) Premarket Notification, meaning these devices were not tested or subject to clinical trials.
Despite injuries and litigation, the market for hernia mesh continues to grow. If you face hernia surgery, be aware that there are non-mesh alternatives available, such as the Shouldice Method.