Unsafe Mesh Was Marketed as Safe
#pelvicmesh #transvaginalmesh #pelvicsurgery #mesh
Mesh Was Marketed as Safe“Mesh material, used to treat pelvic organ prolapse and stress urinary incontinence, was marketed by its manufacturers as a durable surgical method for repairing these challenging problems compared to other corrective surgeries with a high failure rate.” (https://healthblog.uofmhealth.org/womens-health/pelvic-mesh-safe-what-patients-need-to-know). “Early clinical trials suggested excellent efficacy and many surgeons saw advantages over traditional open-surgery procedures, which took longer to perform, involved a longer recovery for patients and were associated with their own range of complications. By contrast, a TVT procedure typically takes 3o minutes, is performed using keyhole surgery and patients often go home the same day. Meanwhile, the traditional treatments for pelvic organ prolapse, which included suturing to reconstruct and repair the affected organs and surrounding tissue, were proving less successful, with reports of up to 29%of women suffering another prolapse after treatment. Hysterectomy is another treatment option, which some women wish to avoid. “Because outcomes of using the mesh for incontinence and hernia were so good people were enthusiastic and confident it would also be good for prolapse,” said Christopher Maher, a urogynaecologist and associate professor at the University of Queensland. “That’s what the mindset was when it was introduced for prolapse around 2002.”” (https://www.theguardian.com/society/2017/aug/31/vaginal-pelvic-mesh-explainer).
Mesh Was Used and Used a Lot“Millions of women over the last two decades have undergone vaginal mesh surgery, but it has recently become clear just how many have experienced severe complications.” (https://www.newscientist.com/article/2178297-the-pain-was-instant-the-devastating-impact-of-vaginal-mesh-surgery/). “About 300,000 women in the U.S. underwent surgery to repair POP in 2010. Surgical mesh was used in about one out of three procedures. About 250,000 women in the U.S. underwent surgery to repair SUI in 2010, with mesh placement being used in over 80% of the procedures.” (https://my.clevelandclinic.org/health/articles/16298-surgical-mesh-use-and-complications-in-women).
Mesh Was Not Safe“We estimated that 9.8% of patients undergoing surgical mesh insertion for SUI experience a complication peri-procedurally, within 30-days or within 5 years.” (https://www.nature.com/articles/s41598-017-11821-w). “Due to reports of complications during or after surgery for POP, in 2016 the FDA changed the classification of surgical mesh to repair POP transvaginally from a moderate-risk device to a high-risk device. The FDA orders apply only to transvaginal use of surgical mesh to treat POP. The orders don’t apply to the use of transvaginal mesh for SUI.” (https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300). Vaginal mesh erosion “is the most common complication following the use of surgical mesh devices to repair pelvic organ prolapse and stress urinary incontinence. 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. (https://my.clevelandclinic.org/health/articles/16298-surgical-mesh-use-and-complications-in-women). Along with Scotland, the United Kingdom, and Australia, New Zealand had something to say about the so called safety of transvaginal mesh, even going to the point of effectively banning its use: “New Zealand’s Ministry of Health wrote letters to the manufacturers of mesh – including midurethral slings – requesting that they stop marketing their products in the country, unless they could produce evidence proving their safety and efficacy. This effectively results in a ban in all transvaginal mesh, including SUI treatments.” (https://www.augs.org/update-on-vaginal-mesh-for-prolapse-and-incontinence/).