Prior to the development and widespread marketing of pelvic mesh devices, surgery for SUI and POP was seen as unattractive, except in the most severe of cases, as the benefits of undergoing surgery generally did not outweigh the risks associated with undergoing the surgery. However, pelvic mesh manufacturers seemingly revolutionized this field by offering a solution to the conditions of both SUI and POP through ‘safe and effective’, ‘minimally invasive’, out-patient procedures with speedy recovery rates. Unfortunately, there is a growing body of evidence, which confirms that many mesh manufacturers did so without fully and truthfully disclosing the risks associated with the use of pelvic mesh devices.
It is alleged that mesh manufacturers, via publication and distribution of brochures and other marketing material and instructional pamphlets, including instructions for use, represented that pelvic mesh devices had performance characteristics, benefits, and qualities of being safe and effective for the treatment of SUI and POP. These manufacturers further represented that the surgical use of the pelvic mesh devices was a safe, effective, and less invasive treatment for SUI and POP, while minimizing the risks of the complications and exaggerating the benefits of the use of these devices.
These representations were allegedly made by mesh manufacturers with the intention of, and had the effect of, inducing patients and their medical practitioners to favour treatment of SUI and/or POP with the surgical implantation of pelvic mesh devices, over other alternative forms of treatments.
These representations are alleged to have been false in that mesh manufacturers knew and failed to disclose to, or to correct and warn against any misapprehension by patients and their medical practitioners that the pelvic mesh devices suffered from defects and that:
- injuries could develop, the pelvic mesh devices carried higher risks of complications than alternative treatment options,
- the pelvic mesh devices had a negative risk-benefit ratio such that the risk of harm outweighed the benefit from the use of the pelvic mesh devices as a treatment for SUI and/or POP; and
- the pelvic mesh implants had not undergone proper of adequate pre- and post- market clinical evaluations (including clinical trials).
It is alleged that mesh manufacturers knew, or ought reasonably to have known that patients as well as their medical practitioners would act on the assumption that the representations were true and accurate whereas they were in fact false, misleading and/or deceptive at the time they were made. As a result, patients were surgically implanted with pelvic mesh devices which suffered from defects and which, in turn, caused them to suffer injuries.
RH Lawyers Inc. (“RHL”) and Richard Spoor Inc. (“RSI”) have launched class action proceedings in South Africa against Johnson & Johnson, Coloplast and various other associated manufacturers and distributors of pelvic mesh, on behalf of class members who have been injured as a result of being implanted with defective pelvic mesh devices.
Individuals who have suffered harm as a result of being implanted with defective pelvic mesh are encouraged to contact RH Lawyers as soon as possible by either:
- Emailing: info@rhlawyers.co.za;
- Calling 087 188 2698; or
- Sending a please call me or WhatsApp to 062 973 9224
