Transvaginal Mesh History and Litigation

Transvaginal Mesh History and Litigation

Transvaginal Mesh Defective Medical Device Lawsuits

Transvaginal Mesh is an extremely controversial product that is highly debated in the medical and legal fields because of its lack of efficacy. Throughout the years of continued use, many women have had resulting adverse reactions that are often debilitating and life-threatening.

Transvaginal Mesh Litigation History

Originally mesh was used for hernia repair in the 1950s. After some doctors began with trial and error in the 1970s, many physicians started using mesh abdominally to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). At this time, they took mesh and personally concocted it to shape and size it for use in a particular patient. As usage expanded, after successful surgeries helped women, many medical device manufacturers took notice and began creating mass mesh products specifically designed to treat POP and SUI. This mass appeal permitted manufacturers to design kits that instructed doctors on how to perform the surgery needed to implant the device properly. Mesh kits for the repair of POP were first marketed to urologists and gynecologists as a way to improve success rates for POP repairs with native tissue, but without well-designed trials to establish the safety and efficacy of these devices [1]. Since the mesh was already approved for other surgeries, it wasn't thought to be dangerous and the FDA even approved of the first manufactured device by Boston Scientific in 1996 [3].

What is Transvaginal Mesh?

Transvaginal mesh, as formally mentioned, is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women:

• Pelvic organ prolapse afflicts women after childbirth and menopause. It occurs when weakened pelvic muscles allow the balder, uterus or rectum to “fall” or sink into the vagina. During this defect, organs sag into the vaginal canal because of the weakened pelvic muscles. The mesh serves as a hammock beneath the organs to hold them up. The bladder is the most common organ involved in the failure. Depending on the organs involved, surgeons may place the piece of mesh on the front, back, or top wall of the vagina. It varies in shape and size and it is mostly (3 out of 4 surgeries) performed transvaginally.
• Stress urinary incontinence occurs when the bladder leaks urine during moments of increased physical activity which then increases the pressure on the bladder. The unintentional loss of urine happens during movements such as coughing, sneezing, running, etc. The mesh is used to support the urethra when pelvic muscles are weakened. Such surgical treatment of SUI with mesh is usually called a bladder sling or vaginal tape and is the most common type of surgery used to correct the condition. Just like POP, SUI surgeries are mostly done transvaginally- roughly 80% [2].

The mesh is mostly made from synthetic material such as polyester or plastic or polypropylene. The term transvaginal refers to the type of technique used to implant the mesh through the vagina and into the area needed. It is thought to be quicker and less invasive. As such, manufacturers have come up with four separate groups of mesh products, formulated by the FDA, that are aimed in preventing POP or SUI. These categories include non-absorbable synthetic, which is considered a permanent implant and is the most popular; absorbable synthetic mesh, which loses its strength over time and is not intended as a long-term treatment; biologic products are natural and derived from animal tissue that has been disinfected for implanting in the human body; and composite mesh, which is made from a combination of any of the aforementioned categories.

The Dangers of Transvaginal Mesh

The forms of treatment listed have been increasingly used in the past 8 years as opposed to traditional methods. However, there is no evidence to suggest or document either effectiveness or safety. With many women using these mesh products to aid in the after-effects of childbirth, menopause, or hysterectomies, the dangers that were later confronted garnered thousands of women to come together in an effort to get compensated for injuries sustained. In 2011, the FDA reported that it had received 4,000 reports of complications related to transvaginal mesh in the previous 6 years. The agency contended that these results shifted their former “rare” status in 2008 to a more prevalent status in 2011 of product defectiveness [4]. Continually, the agency recently proposed to reclassify the mesh devices used for POP from a moderate-risk device to a high-risk device in April of 2014. Bladder slings used for SUIs on the other hand have not been called out by the FDA when in regard to public safety. Still, the FDA did say indicate that they would comment on this device in the future [5]. The complications that may arise due to mesh implants include a multitude of issues such as:

• mesh erosion through the vagina
• pain
• infection
• bleeding
• painful intercourse
• organ perforation
• urinary problems

Two of these complications have made the most impact on women's lives and have led to other problems. Mesh erosion and organ perforation continue to be detrimental to treated women.

Mesh Erosion

Mesh erosion is one of the most serious effects of transvaginal mesh surgery. It occurs when the mesh device moves through the vaginal wall and sometimes into surrounding organs. It can be extremely painful and can lead to exposure. This means that the mesh may be visible externally. Mesh erosion may lead to painful sexual intercourse, damage to the bladder, recto-vaginal fistula (the small tunnel that connects the rectum with the vagina), an abscess, and intense pain among many other symptoms. In 2011, the FDA reported that the “erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries.” Also on the FDA website, the agency states, “erosion of mesh slings thorough the vagina is the most commonly reported mesh-specific complication form SUI surgeries with mesh. The average reported rate of mesh erosion in one year following SUI surgery is approximately 2%.” In May 2014 Dr. Jerry Blaivas, who spoke at the annual American Urological Association (AUA), stated that this statistic should be increased to 4% because such complications are underreported [6].

Organ Perforation

Organ Perforation happens when the device penetrates the wall of a hollow organ in the body. As the mesh erodes through internal tissues, it can puncture (perforate) organs. The affected organs usually include the bladder, urethra, bowel, or rectum. On some rare occasions, the perforation occurs during the surgery to place the device within the specified area. Difficult cases of organ perforation may result in infection and difficulty breathing. Surgery is almost always required and may include the removal of mesh, bowel resection, colostomy, and blood transfusion. In 2011, a study comparing the colporrhaphy and transvaginal mesh procedures, Swedish researchers studied 389 women with pelvic organ prolapse and discovered that 200 of the women who underwent transvaginal mesh repairs had a 3.5% greater incidence of bladder perforations than the 189 women who underwent colporrhaphy surgery [7]. The FDA found that between the years 2008 and 2010, about 5.8% of reports involved organ perforation.

What do all of these statistics mean?

The physical and emotional harm can affect women's work, relationships, and daily activity. Some experts say argue that the surgical mesh is not safe for transvaginal placement and is not properly tested for future use.

Recent Transvaginal Mesh Litigation

To make an impact against the manufacturers of mesh devices, more than 49,000 federal lawsuits against these mesh makers have been filed in the U.S. District Court for the Southern District of West Virginia under Chief Judge Joseph R. Goodwin. Devices that have the most lawsuits against the manufacturers are American Medical systems and Ethicon. Boston Scientific, C.R. Bard, Coloplast, Cook Medical, and Neomedic have all been in litigation for their defective devices as well. Cases:

• In May 2015, a jury there awarded a 51-year-old former bank teller $25 million in compensatory damages and $75 million in punitive action against Boston Scientific Corp. Deborah Barba said she suffered constant discomfort, urinary tract infections, and painful sex—despite two corrective surgeries—because of being implanted with the company's transvaginal mesh. Boston Scientific said the company would pay $119 million to settle nearly 3,000 of the suits [8]. However, while the jury had properly decided the company's liability, Johnston wrote in her ruling that the jury's award was too high, particularly in comparison with the other mesh trials, in which punitive damages awards spanned from $1.75 million to $7.76 million. Therefore, the compensation was reduced to 10 million [10].
• Legal-Bay LLC, The Lawsuit Settlement Funding Company, reported that Johnson & Johnson's Ethicon unit requested a Texas appellate court to throw out a $1.2 million jury verdict against them. The jury awarded a woman who said she was injured by Ethicon's TVT-O pelvic mesh; however, Ethicon is requesting the verdict toss because they believe there wasn't enough evidence that the product was defective in its design. Ethicon also argued that the woman only had "speculative evidence" that her injuries may have been caused due to the defective mesh product. The $1.2 million verdicts were awarded to the woman in April of 2014, however, the jury declined to award any punitive damages after finding that Ethicon provided adequate warning of the risks that were known [9].

Seek an Experienced Defective Medical Device Attorney

If you or a loved one has undergone transvaginal mesh surgery to prevent the negative effects of SUI or POP and are instead experiencing pain and suffering or losses of any kind, don't hesitate to get in touch with the experienced product liability attorneys of Dolman Law Group Accident Injury Lawyers, PA. If the medical organization that provided the surgeon failed to warn you of the serious dangers that arise from having a transvaginal mesh, you may be eligible for compensation. Here at Dolman Law Group Accident Injury Lawyers, PA in Clearwater, Florida, we have experience in dealing with companies that sell harmful or hazardous products. Consumers have rights and we strive to protect those rights. Contact us for a free consultation and case evaluation to learn your rights and options. Call 727-451-6900 or fill out a contact form online today. Dolman Law Group Accident Injury Lawyers, PA 800 North Belcher Road Clearwater, Florida 33765 727-451-6900 References: [1] https://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Vaginal-Placement-of-Synthetic-Mesh-for-Pelvic-Organ-Prolapse [2] https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300 [3] https://www.drugwatch.com/transvaginal-mesh/ [5] https://news.topwirenews.com/2015/10/02/transvaginal-mesh-update-sling-victims-avoiding-multi-district-litigation/ [6] Renowned Urologist for the Plaintiffs Does Not Use Synthetic Mesh [7]  Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse [8]https://www.abajournal.com/news/article/jury_in_delaware_awards_100m_to_51_year_old_woman_in_transvaginal_mesh_case [10] https://www.insurancejournal.com/news/east/2015/10/13/384645.htm