Pelvic Mesh Devices: Frequently Asked Questions

1. WHAT IS A PELVIC MESH DEVICE?
   Pelvic mesh is a medical device that is typically a sheet of woven or net-like material which is implanted into the human body to provide support to weakened or damaged tissue.

2. WHAT ARE THE PELVIC MESH DEVICES USED FOR?

Pelvic Mesh Devices are used for the treatment of pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). POP is a medical condition in which the tissue supporting the pelvic organs (the bladder, uterus, or bowel) weakens, causing these pelvic organs to bulge down against the vagina or to push past the vaginal opening. SUI occurs when pelvic support structures to the bladder and urethra are damaged or weakened, resulting in urine involuntarily leaking from the urethra during physical activities such as coughing, sneezing, exercising or laughing.

3. WHAT ARE THE MOST COMMON COMPLICATIONS AND SYMPTOMS ASSOCIATED WITH THE IMPLANTATION OF PELVIC MESH DEVICES?

• Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel;
• Mesh extrusion, expulsion or erosion into the vaginal tissue or other organs;
• Acute and/or chronic pain; or neuromuscular problems;
• Chronic inflammation of the tissues surrounding the implants;
• Feeling pressure or protrusion from the vagina;
• Lower back, low abdominal, pelvic, groin, thigh or buttock pain;
• Leg weakness;
• Experiencing pain during sexual intercourse;
• Abstinence from sexual intercourse;
• Pain associated with urination;
• Chronic / abnormal vaginal drainage, bleeding or discharge;
• Psychiatric injury.; and
• Vaginal infections, scarring or shrinkage; 

4. WHAT IS THE MAIN CAUSE FOR PELVIC MESH RELATED COMPLICATIONS?

The pelvic mesh implants are composed of polypropylene which is not biocompatible as a permanent implant in the body and is therefore unsuitable for its intended use. The lack of biocompatibility causes degradation of the mesh over time, causing inflammatory reactions from the body to the mesh. The mesh implants can also be subject to mesh shrinkage, mesh hardening, mesh migration, mesh deformation and mesh erosion.

5. WHAT ARE THE DIFFERENT TYPES OF PELVIC MESH DEVICES WHICH ARE SUBJECT TO THE CLASS ACTION?

The different types of pelvic mesh devices manufactured by Johnson and Johnson and Coloplast include but are not limited to the following devices:

• The TVT device;
• The TVT-O device;
• The TVT-Secur device;
• The TVT-Exact device;
• The TVT-Abbrevo device;
• The Gynemesh PS device;
• The ProLift device;
• The ProLift+M device;
• The Prosima device;
• The NovaSilk Synthetic Flat Mesh device;
• The Restorelle Smartmesh device;
• The Exair Mesh device;
• The Aris Transobturator, Minitape and Omnisure Sling devices; and
• The Supris Sling device.

6. WHAT CAN BE DONE IF I EXPERIENCE PELVIC MESH RELATED COMPLICATIONS?
   
   Women who have experienced pelvic mesh related complications may be required to have the mesh device surgically removed.

7. HAS THE IMPLANTATION OF PELVIC MESH DEVICES BEEN PROHIBITED IN SOUTH AFRICA?

The use of mesh implants has been banned in countries such as the USA, Australia, and New Zealand. On the contrary, majority of pelvic mesh devices were unregulated when introduced to the South African market and equivalent warnings and/or restrictions are yet to be issued in South Africa. The mesh devices have, however, been categorized as moderate-high to high-risk medical devices in South Africa.

8. WHO IS LIABLE FOR THE INJURIES SUFFERED BY WOMEN AS A RESULT OF THE IMPLANTATION OF THE PELVIC MESH DEVICE?
   
   The class action lawsuit seeks to hold manufacturers and/or distributors and/or suppliers liable for the harm suffered by women implanted with mesh devices, as well as the psychological and emotional trauma suffered by spouse(s), partner(s) and/or individuals in a close relationship with these women as a result of the breakdown and dissolution of these relationships.
   
   
   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 were 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.