Are You Aware Of The Dangers Of Surgical Mesh?
Hernia, a condition affecting thousands of men and women in the United States each year, is the protrusion or projection of an organ or tissue through the wall that normally contains it.
Until 1958, abdominal wall hernias were repaired without mesh. In 1958, Dr. Frances Usher published a medical journal article entitled Marlex mesh, a new plastic mesh for replacing tissue defects. Dr. Usher used polypropylene mesh in experimental canine work for abdominal repair. Polypropylene is a petroleum-based plastic initially used in the Hula-Hoop and for kitchen storage applications. Heavily promoted by the medical device manufacturers, hernia mesh, typically made wholly or partly of polypropylene, is frequently used in hernia repair surgery. About one million hernia repair surgeries with mesh are performed world-wide each year. Despite the marketing efforts by mesh manufacturers to persuade doctors to use mesh in hernia repair, many doctors steer away from polypropylene mesh and use the Shouldice technique for hernia repair.
The Shouldice technique, used for decades, is a mesh-free hernia repair method. It has been known since 1953 that any implanted device must not be physically modified by tissue fluids, be chemically inert, not incite an inflammatory or foreign body cell reaction, be non-carcinogenic, not produce allergic reactions, and be able to withstand mechanical stress. D. Ostergard, Degradation, Infection and Heat Effects on Polypropylene Mesh for Pelvic Implantation: What Was Known and When it Was Known, 22 INT’L UROGYNECOLOGY J. 771-774 (2011).
Polypropylene is not biologically inert in the human body, and can cause serious injuries. A typical response to mesh implanted in the human body is inflammation, granuloma formation and a foreign body reaction. Scar tissue forms around the implant and causes contraction of the mesh up to 50%. This inflammation, foreign body response and scar tissue formation is a permanent condition and can result in long-term complications. U. Klinge et al., Foreign Body Reaction to Meshes Used for the Repair of Abdominal Wall Hernias, 165 EUR. J. SURGERY 665-73 (1999).
Despite the promotion of mesh as safe and effective by Defendants, the published medical literature contradicts this unsupported belief. One author observed that “[t]he literature suggests otherwise with reports of various degrees of degradation, including depolymerization, cross-linking, oxidative degradation by free radicals, additive leaching, hydrolysis, stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis.” The author concluded, “Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body.” G. Sternschuss et al., Postimplantation Alterations of Polypropylene in the Human, 188 J. UROL. 27-32 (2012).
As the mesh degrades in the human body, small flakes of polypropylene can lead to infection and irritation, and resultant serious pain, as the body tries to rid itself of the foreign material. Once implanted, mesh contracts as well as cracks substantially in the human body. In one study, a contracture rate of 30% to 50% was found four weeks after implantation. Another study reported an 85% contracture rate after eight years. Nerve fibers are entrapped in the contracted tissue causing severe pain. A debilitating consequence of hernia repair with mesh is inguinodynia, or chronic groin pain. This condition results from nerves, such as the ilioinguinal, iliohypogastric and genitofemoral nerves, coming into contact with mesh, after its degradation and deformation in the body following implantation, and from the persistent and permanent foreign body reaction to the implantation of mesh. It has been reported that hernia repair with mesh results in an extraordinarily high rate of inguinodynia—in some reports approaching 50%. See, e.g., J.E. Fischer, Hernia Repair: Why Do We Continue to Perform Mesh Repair in the Face of Human Toll of Inguinodynia? 206 AMER. J. SURG. 619-23 (2013). Other studies have found an even higher rate of chronic pain after hernia repair with mesh. One study found that approximately 75% of patients had pain one year after hernia repair at rest, and 78% had pain when moving. B. Page, Pain From Primary Inguinal Hernia and the Effect of Repair on Pain, 89 BRIT. J. SURG. 1315-18 (2002).
Despite the abundance of scientific and medical information published in the literature relating to the dangerous properties and serious risks of polypropylene mesh, mesh manufacturers made a deliberate decision to ignore these dangers and to aggressively promote polypropylene mesh to healthcare providers and consumers. Manufacturers oncealed from physicians and consumers, the serious risks, dangers and defects associated with polyproppylene mesh.
Klieman & Lyons is now accepting and litigating cases on behalf of clients who have suffered injuries as a result of medical implants. To learn more, call (617) 443-1000.