J&J, Coloplast face class action lawsuit in SA for devices allegedly causing vaginal injuries

Two legal firms are hauling medical giants Johnson & Johnson (J&J) and Coloplast, as well as other associated manufacturers and distributors of defective pelvic mesh devices, to the South Gauteng High Court in Johannesburg, seeking certification of a class action from the manufacturers.

Legal representatives from RH Lawyers and RH Spoors have said that the Class Action intends to seek compensation for women that received pelvic mesh devices implants via surgery from 1996 to date and have suffered harm as a result of the pelvic mesh devices being defective.

Pelvic mesh devices

Urogynaecological meshes, also know as pelvic mesh devices, are used to treat pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when one or more of the organs in the pelvis slip down from their normal position and bulge into the vagina. These organs can include the womb, bowel, bladder or top of the vagina.

As a result, symptoms include a feeling of heaviness around the lower abdomen and genitals, a dragging discomfort inside the vagina, feeling like there’s something coming down into the vagina, discomfort or numbness during sex, and problems urinating – such as feeling like the bladder is not emptying fully, needing to go to the toilet more often, or leaking a small amount of urine when one coughs, sneezes or exercises.

The condition is very common in women after childbirth or during menopause. Around 20% of women are affected by it.

Stress urinary incontinence is the condition where urine leaks out when the bladder is under pressure; for example, when one coughs or laughs.

The mesh is used to for the treatment of both of these conditions. It is a net-like implant that comes in a number of forms, such as a sling, tape, ribbon, mesh and hammock. It is inserted into the body surgically to prop up the sagging organ and is held in place by sutures or tissue fixation devices.

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Problems with these surgeries

But it has been suggested that these mesh devices are causing more harm than good. According to My Cleveland Clinic, the most common complication has been vaginal mesh erosion. It said that non-absorbable synthetic surgical mesh, such as that made of polypropylene or polyester, can break down or wear away over time. Part of the mesh may become exposed or protrude through the vagina.

The mesh was also known to have eroded into the urethra, bladder or rectum, but this has been less common. It was also said that shortening or tightening of the mesh over time could occur and could cause vaginal shortening, tightening or pain.

The legal firms explained that as a result of the device’s degradation, the pelvic mesh device hardens, cracks and becomes deformed. This in turn has resulted in various complications such as cutting into tissue, chronic inflammatory responses, excessive scar tissue build-up and mesh perforating tissue or eroding through the pelvic wall.

Over 50% of women who experienced erosion with non-absorbable synthetic mesh needed to have the mesh surgically removed. Even so, the pain was still experienced after the mesh was removed.

Compensation sought

It was for this reason that the legal firms are representing all persons who, from 1 January 1996 to the date of certification, underwent a surgical procedure in South Africa to implant a mesh device made from polypropylene.

The legal firms estimate that in South Africa there are several thousand women affected by the defective mesh devices, manufactured by Johnson & Johnson, Ethicon and Coloplast.

The applicants in this South African class action allege that the pelvic mesh devices were defective and not fit and safe for use in the treatment of pelvic organ prolapse and stress urinary incontinence. They claim this resulted in them suffering bodily injuries, and members of the secondary psychological class suffering a foreseeable psychiatric injury as a result of the injuries to their close family member.

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Banned in several countries

During April 2019 the US Food and Drug Association ordered manufacturers of certain pelvic mesh devices to stop selling and distributing them as they were unsafe for surgical use. Medical regulators in Australia, New Zealand and the UK have also imposed bans on the use of mesh implants due to the risks and high rates of complications.

More than 1 350 Australian women won a long-running class action lawsuit against J&J and Ethicon over claims that their vaginal mesh products were defective and unsafe. The judge in the case also found that the mesh manufacturers failed to adequately warn of the serious risk of injury associated with the mesh implants.

Following this decision, J&J settled the Australian mesh class action for over R3 billion. This was the largest settlement in a product liability class action in Australian history.