Over the last several years the FDA has identified many surgical mesh manufacturers with defective mesh products leading to a number of product recalls. Recipients of surgical mesh have reported to the FDA painful and debilitating complications from a variety of surgeries in which surgical mesh was used. Faulty surgical mesh surgeries and products can cause painful injuries that appear immediately or years after the initial surgery, and unfortunately in some cases, these symptoms can continue for a lifetime particularly when there is permanent nerve damage and/or when the mesh cannot be entirely removed safely.
In women, extremely painful and often severe complications have arisen from the placement and failure of transvaginal surgical mesh, bladder slings and various other products/techniques used to treat conditions such as Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Complications include infections, pain, urinary problems, vaginal scarring, mesh erosion through the vaginal tissue and reoccurrence of POP or SUI along with perforations of the bowel, bladder, blood vessels or death.
In some cases, the mesh cannot be completely removed due to the integration into the body, and the patient’s health is continuously compromised for life, requiring ongoing medical monitoring and treatment.
There are a number of companies that manufacture and distribute various mesh products. The products are made out of a wide variety of materials and combinations of materials from polypropolene and polyeurethene to various polymer, biologic and animal based materials. Most of these products were introduced into the market without sufficient research or human trials. Most of the products have used/abused the abbreviated FDA 510k process in order to avoid pre-market testing and approval processes. The companies have marketed the products in an extremely aggressive manner to physicians and hospitals who in turn have also generated large revenues from the use of these devices in surgical procedures. Most doctors rely on the manufacturers for information about the product and its risks/safety profile. This information is routinely incomplete and misleading and in some cases materially false and deceptive. In turn, patients are frequently not advised of risks, what product is used or even that a mesh product will be used. Often there is not even a mention of the mesh on informed consent forms.
There are complicated medical, scientific and regulatory issues involved in these cases as well as a deep and primarily financially based resistance from both manufacturers and many physicians preventing their full acknowledgement of the serious health problems caused by these dangerous and defective products.
At Mueller Law we have dedicated substantial time and resources and are working closely with other dedicated legal and medical professionals in order to understand and effectively pursue legal remedies for the damages caused by these products.