“One of the biggest manufacturers of vaginal mesh implants, C.R. Bard, is ending all production and marketing of the controversial products after years of campaigning by women around the world.” (https://www.icij.org/investigations/implant-files/leading-manufacturer-exits-vaginal-mesh-market/).
Some Quick Points about Transvaginal Mesh
"Unfortunately, an increasing number of women report serious complications from transvaginal mesh used for prolapse that severely impact their quality of life." (https://obgyn.ucla.edu/mesh-related-complications). "Research has shown that surgical mesh for transvaginal repair of POP can cause complications such as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation and urinary problems. Many of these complications require additional treatment, including surgery." (https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300). "Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products." (https://www.massdevice.com/report-fda-panel-wants-more-extensive-data-quality-of-life-outcomes-for-vaginal-mesh-products/). "Australia and Britain have stopped vaginal mesh implants — California should, too." (https://www.sfchronicle.com/opinion/openforum/article/Australia-and-Britain-have-stopped-vaginal-mesh-13315968.php).
“Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue.” (https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300). No doubt, you’ve seen the reports (some disguised as commercials) about the dangers of pelvic mesh. You probably wouldn’t have found this posting if you weren’t looking for more information. Let me start by saying the idea of surgical repair using a net is not new, not bad in and of itself, and has helped many women. Let me also say that this product has made an enormous amount of money for the manufacturers and distributors of mesh. And, it has made a lot of money for the surgeons who implant this mesh. When there is so much money to be made, people get greedy and downplay risks while overemphasizing benefits. Misrepresentations were made to the public and to the doctors.
Some doctors quickly realized the dangers of mesh surgery for Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence (“SUI”) and reserved the procedure to those limited situations where the benefits outweighed the risks. “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). ” The FDA has “planned to convene an advisory committee meeting to share the available evidence and seek expert opinion on the evaluation of the risks and benefits of these devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.” (https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm). “The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% ” (https://www.nature.com/articles/s41598-017-11821-w).
Some doctors believe that, despite the high risks of complications, they can implant mesh safely. “Vaginal mesh can be a safe and effective treatment option when used for the right candidates by experienced surgeons who are skilled in the appropriate surgical techniques. “Complications can occur with any surgery,” explained Dr. Visco, but those complications can be minimized when surgeons select appropriate candidates for the procedure and when doctors are skilled in the proper surgical techniques and experienced with vaginal mesh procedures. In addition, surgeons who utilize mesh should have had training on how to manage mesh complications.” (https://www.dukehealth.org/blog/vaginal-mesh-dangerous-learn-facts).
And then, it appears that some doctors turned a blind eye to the risks and implanted mesh in any patient they could talk into getting surgery, because “millions” of women had mesh implanted. “In the last two decades, millions of women have turned to vaginal mesh implants as a possible solution to two annoying problems: urinary incontinence and pelvic organ prolapse, where body parts shift out of place due to childbirth or the ageing process.” (https://www.thedailybeast.com/the-million-dollar-deal-behind-the-vaginal-mesh-implant-mess).
According to the Cleveland Clinic, some complications associated with mesh implants are:
– Vaginal mesh erosion: This 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
– Vaginal mesh contraction: Shortening or tightening of the mesh over time can cause vaginal shortening, tightening, or pain
– Pain during sexual intercourse
– Urinary problems
– Tearing of organs
– Pelvic organ prolapse that returns
– Emotional problems
If you, a family member, a loved one, a friend, or anyone you know has had pelvic surgery that involves mesh and had complications wherein the mesh fell apart, it may be time for you or that other person to contact a lawyer. There are statutes of limitations (deadlines), so waiting too long can mean no case. Paul J. Molinaro, M.D., J.D. offers free consultations on mesh cases for patients who had surgery in California.