The class action, led by RH Lawyers and attorney Richard Spoor, seeks compensation for South African women who have suffered harm following the implantation of the pelvic mesh devices, which are used for the treatment of pelvic organ prolapse and stress urinary incontinence.
The class action has been initiated in the South High Court in Johannesburg. Also actioned against Ethicon, Coloplast and Nuangle, it comes in light of a landmark ruling out of the Federal Court of Australia in November 2019, wherein Ethicon and Johnson & Johnson were ordered to pay $1.7m (R31m) to three women in Australia.
It was found that Johnson & Johnson and it's subsidiaries had misled patients and surgeons about the risks associated with their pelvic mesh products.
In a statement, Spoor said the pelvic mesh devices have been shown to contain defects that render them unfit and unsafe for use as permanent medical implants.
"They result in numerous post-operative complications that are significantly higher than that of comparable products and medical procedures.
"The nature of the defects arises from the fundamental incompatibility of polypropylene for use in a permanent mesh implant in the pelvic region of the human body.
"The design and procedure for implantation of the pelvic mesh devices prevents and/or precludes the ability to surgically remove or excise the pelvic mesh devices once implanted due to the integration of the device into surrounding bodily tissue."
These defects cause, as well as materially contribute to, numerous adverse health conditions and medical complications leading to injury and bodily harm, he said.
He said these include painful recurrent erosions and intractable chronic pain, excessive blood loss and vascular damage, permanent nerve injury, subclinical infections, erosion and inflammation of tissue, migration, a build-up of seromas, nerve entrapment and sexual dysfunction.
"At least some of the aforesaid companies failed to adequately warn or instruct women implanted with these pelvic devices of the defects, the associated and increased risks of complications and the fact that treatment of pelvic organ prolapse and stress urinary incontinence with the use of trans-vaginal mesh is less effective than safer alternative treatments," Spoor said.
In a statement, RH Lawyers commented that, should the application for certification be granted by the court, the applicants will proceed to trial for determination on two aspects.The first will determine the liability of the respondents, and the second will assess the quantum of damages payable to each class member.
In the wake of the class action, Ethicon responded, saying: "Patient safety is our first priority. Pelvic mesh has helped improve the quality of life for millions of women with stress urinary incontinence and pelvic organ relapse."
Coloplast's Peter Monster said: "We are committed to the women's health business."
"We believe our mesh products improve lives and are a safe and valuable option for surgeons who treat women with pelvic organ prolapse and stress urinary incontinence."
He added that the firm does not comment on specific lawsuits.