Australia is the first country to ban the controversial transvaginal mesh patch medical device designed to treat pelvic organ prolapse and urinary incontinence. In banning the mesh patch, the Australian authorities cited the device’s design defects and the many health problems associated with the mesh.
Patient safety advocates in the United States hailed the move and called on the FDA to follow suit.
“I do believe the FDA is watching what happened with the vaginal mesh implant ban in Australia,” Orlando-based urogynecologist and Drugwatch expert Dr. Christopher Walker said. “I support a ban on these products and hope they are banned in the U.S. as well.”
The Therapeutic Goods Administration — the Australian equivalent to the U.S. Food and Drug Administration — announced this week its decision “to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods.” Transvaginal mesh implants remain available in the U.S., despite pleas from local doctors and patient advocates to have the products banned.
The ban includes single incision mini-slings, small mesh strips used to treat urinary incontinence. It also includes mesh products from Boston Scientific and Coloplast, two companies involved in transvaginal mesh lawsuits in the U.S.
“When you place this foreign object into the vagina, you are placing bacteria into the tissue where the mesh is placed, causing chronic inflammation and other problems,” said Walker, who has treated a large number of women for complications from mesh implants, often with multiple surgeries.
Patients of transvaginal mesh have complained that the manufacturers provided false and misleading information about the safety and effectiveness of the mesh. Many victims have suffered permanent and debilitating injuries due to the mesh. But it doesn’t just stop there. Other counts in mesh lawsuits include:
- Failing to conduct appropriate and sound research and testing to identify risks of mesh for female pelvic disorder treatments.
- Failing to establish consistently safe means for mesh removal.
- Neglecting to warn customers of potential injury and risks.
- Purposefully misrepresenting the safety and effectiveness of transvaginal mesh to the FDA, large medical community, and patients.
Many patients experienced their transvaginal mesh eroding through the vaginal walls just weeks after surgery. This impacts regular activities like sitting, walking, and sexual intercourse. The physical and emotional harm that is caused from such a painful and uncontrollable process negatively impacts work abilities and relationships. If that weren’t enough, patients with bad mesh end up needing multiple surgeries to fix not only the original problem but the dangerous issues caused by the mesh.
I applaud Australia for taking decisive action against this dangerous medical device. Our own regulatory agency, the FDA, should do likewise. If you or a loved one have been injured by a transvaginal mesh, contact me today for a free consultation.
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