A dozen South African women are following counterparts in Western countries in suing pharmaceutical companies for chronic harm they say was inflicted by implants designed to treat incontinence and other ailments, reports News24.
The polypropylene device, called a trans-vaginal mesh (TVM), is designed to work as an internal support to treat urinary incontinence and prolapse that most commonly occur after childbirth.
The South African group is bringing a class action suit against Danish medical device manufacturer Coloplast and Ethicon, a subsidiary of US pharmaceutical giant Johnson & Johnson. Their representatives intend to launch the case, the first action against TVM in Africa, by August.
Ethicon reportedly told AFP that pelvic mesh has “helped improve the quality of life for millions of women”.
“We empathise with those who have experienced complications,” the company said, adding: “Ethicon has acted ethically and responsibly.”
J&J has already lost class actions in Australia and the United States for injuries caused by its device. In January 2020, a US judge ordered the firm to pay $344m (€291m) for false and deceptive marketing of pelvic mesh products in California.
Unlike South Africa, in 2016, the United States classified mesh used for pelvic organ prolapse as a “high-risk device” and banned its sale in 2019. Complications occur in up to a quarter of women, according to a study by BioMed Research International.
And according to a report in The Guardian in 2017, “most short-term clinical trials have found high efficacy and low complication rates for the most common mesh implants (TVT) used for incontinence, but there is a growing body of evidence that efficacy is lower and complication rates are higher for pelvic organ prolapse”.
The report added that there was also little robust information on the success of the procedures in the long term and when carried out in the wider population. “However, there are indications that complication rates could be significantly higher than those typically reported in trials – in the UK, NHS data suggests that one in 15 women later has to have their implant surgically removed.”
See more from Medical Brief archives: