The United States of America
In the United States, the Food and Drug Administration (FDA), in April 2019, ordered manufacturers of all remaining mesh implants indicated for the transvaginal repair of POP to stop selling and distributing their products in the U.S immediately. This is the latest in a series of escalating safety actions related to protecting the health of women who have undergone surgery transvaginally to repair POP.
Australia
In December 2017, the Australian Government removed certain mesh implants whose sole use is the treatment of pelvic organ prolapse (POP) via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG). The ATGA was of the belief that the benefits of using mesh implants in the treatment of POP do not outweigh the risks these implants pose to patients.
New Zealand
New Zealand followed suit after in January 2018, when it announced action to remove from supply, and effectively limit the use of certain mesh implants In essence, their response was to effectively place a limit on the supply of mesh implants for the repair of POP and SUI rather than place a limit on the use of surgical mesh for other types of surgery.
Europe
In April 2018, the EU reclassified certain mesh implants used in the treatment of POP and SUI from medium-risk to high-risk- meaning that their marketing and use was subject to higher levels of scrutiny. With this classification, each EU member’s country’s health regulatory authority retains the discretion to decide whether the use and distribution of mesh implants should be restricted.
The steps taken by foreign medical regulators demonstrate the known risks and complications posed by the use of mesh implants.
South Africa
In South Africa there has not been any substantial orders made in relation to any mesh devices. RH Lawyers Inc. (“RHL”) and Richard Spoor Inc. (“RSI”) are currently working on a Class Action Lawsuit in the hopes of changing that.
RH Lawyers Inc. (“RHL”) and Richard Spoor Inc. (“RSI”) have launched class action proceedings against Johnson & Johnson, Coloplast and various other associated manufacturers and distributors of mesh implants, on the basis that the mesh implants were defective. The class action seeks to claim compensation on behalf of class members who were implanted with the mesh, for the harm they suffered as a result.
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.
