“It is estimated, however, that nearly 10,000 of U.S. Essure patients required additional operations after their original procedure. This is due to anything from severe side-effects, the device traveling to different areas of the body, or perforations and tears requiring medical procedures. Dr. Katy Moncivais, PhD, Medical Writer tells me: “Essure fails every test – it’s less safe, less effective, and more side effect prone than most other methods of birth control.” ” (https://www.girlsglobe.org/2019/04/03/womens-reproductive-health-under-attack/).
“The FDA requires a Premarket Approval (PMA) to review and evaluate the safety and effectiveness of Class III medical devices like Essure. FDA regulations require that this takes 180 days, and normally longer, but there are records that show that this process was expedited and several trial candidate’s records were altered to obscure unfavorable data. Some patients were completely thrown out of the clinical trials when their data reflected poorly on the device. According to the citizen’s petition linked above, there were many adverse events that Essure manufacturers and PMA holders failed to report and/or covered up. Additionally, over 16,000 patient complaints were withheld from the FDA. When the manufacturing facilities were inspected, many unsettling thing came to light, starting with the facility’s lack of license. The manufacturer of Essure were operating without a license for three years.” (https://www.hormonesmatter.com/essure-debacle/).
“Her last surgery—ostensibly to remove the mesh—was five years ago. “My surgeon told me the mesh was impossible to remove because it was stuck to my bowel and had even migrated to my intestines. Next up I went to a pain management clinic: I have this constant aching pulling feeling and sharp pains like someone is kicking at me. It started just above my belly button but now the pain has spread… and I’ve been on oxycontin [the brand name for Oxycodone] since 2015.”” (https://www.lawyersandsettlements.com/legal-news/mesh-complications/abdominal-mesh-victim-prescribed-oxycontin-could-pain-have-been–23068.html).
“After almost a decade of campaigning by Good Health, the NHS has admitted the material can ‘migrate’ and disintegrate, becoming embedded in tissue. Last July, it said that the tape should not be used for urinary incontinence.” (https://www.dailymail.co.uk/health/article-6900685/Victims-national-mesh-scandal-reveal-agony-housebound-pain-20-years.html).
“Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence.” (https://www.sciencedaily.com/releases/2018/02/180213223410.htm). Polyurethane possesses much more elasticity than polypropylene and is therefore better equipped to sustain the pelvic organs — the bladder, bowel and vagina — exerting pressure on the pelvic floor every day. (https://www.sciencedaily.com/releases/2018/02/180213223410.htm). “Polypropylene (PP) is a nonabsorbable polymer, used widely because of its high tensile strength compare to that of steel. PP is a linear aliphatic hydrocarbon with a methyl group attached to alternate carbon atoms on the chain backbone (-C3H6-). As a result, it is nonpolar in nature, highly hydrophobic, electrostatically neutral and resistant to biological degradation.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5571666/). “The overriding benefit of a PP mesh, however, is that even with its propensity to incite infection; the infections often been treated themselves without the removal of mesh. Additionally, many of the risks associated with PP are being modulated by adjusting mesh weight and porosity to promote more or less tissue in-growths. Though obviously not an inert material, PP meshes are considered to be a stable material provides an adequate service to save life.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5571666/). The comments are all recent… so, which do you believe?
More than 100,000 women have filed lawsuits against mesh manufacturers for their injuries, resulting in multimillion dollar verdicts and more than $1 billion in settlements. In 2011, the FDA reported receiving 4,000 adverse event reports caused by transvaginal mesh in the previous six years. In 2016, the FDA changed the classification of transvaginal mesh used to repair POP from a moderate-risk device to a high-risk device. The FDA orders apply only to transvaginal use of surgical mesh to treat POP, and not to the use of transvaginal mesh for SUI. (https://www.nwhn.org/i-was-diagnosed-with-pelvic-organ-prolapse-pop-what-are-the-side-effects-of-a-vaginal-pelvic-mesh-treatment/). “If you wish to find more information on transvaginal mesh, the FDA publishes information about transvaginal mesh and its risks on their website, and there are several transvaginal mesh patient advocacy groups as well as publications such as Public Citizen and Mesh Medical News Desk, which serve to educate the public about the risks of mesh and also information about safer alternatives. ” (https://www.nwhn.org/i-was-diagnosed-with-pelvic-organ-prolapse-pop-what-are-the-side-effects-of-a-vaginal-pelvic-mesh-treatment/).
“Concomitant hysterectomy and hypertension were associated with mesh erosion. In the management of mesh erosion, conservative treatment can be tried as the first-line treatment for smaller erosions, while surgical repair for larger erosions. Recurrent erosions could happen and requires repairs several times.” (https://www.ncbi.nlm.nih.gov/pubmed/28420505).
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/).
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.