Transvaginal mesh (TVM) is a medical device made of a synthetic material that is surgically implanted to provide added strength and support for a woman’s pelvic muscles, which can become weak as a result of age and childbirth.
Transvaginal mesh products, also known as “urogynecologic surgical mesh,” are used to treat pelvic organ prolapse (POP), a condition in which organs in the pelvic area begin to drop and push against the walls of the vagina. POP usually involves the bladder, but the urethra, uterus, cervix, vagina, rectum and small bowel can also prolapse (drop). Transvaginal mesh is also used to treat stress urinary incontinence (SUI), a condition in which weakened bladder muscles can cause incontinence (involuntary urination).
Studies have shown a high failure rate and a significant risk of complications associated with TVM. These problems have led the FDA to issue urgent safety communications about the dangers of TVM. The FDA says the most frequent complications include mesh penetrating the walls of the vagina, infection, pain, urinary problems and recurrence of the prolapse and incontinence.
Problems with TVM have also led to many lawsuits against manufacturers, which have resulted in multi-million-dollar settlements and awards. These lawsuits allege that TVM products were dangerous even when used as intended, that patients were not warned of the risks, and even that companies knowingly used plastic materials in their mesh products that were not safe for human implantation.
If you were harmed by a transvaginal mesh product or are experiencing complications due to TVM implantation surgery, you may be entitled to compensation for the physical injuries and emotional suffering you have endured.
Contact Joye Law Firm to find out what legal options you may have. Call Joye Law Firm now or use our online contact form. There is no fee for the consultation and claim review.
Problems With Transvaginal Mesh
Transvaginal mesh was a popular choice for women with POP or SUI because the mesh material promised a simpler solution than prior treatment methods that involved surgically strengthening weak pelvic muscles.
Within just a few years of the introduction of transvaginal mesh in the late 1990s, hundreds of thousands of women received the implant and complaints quickly began to surface. By 2008, the FDA said it had received more than 1,000 reports of complications linked to transvaginal mesh devices and issued the first of what would become repeated warning about the devices.
TVM products were made by a variety of manufacturers, including Ethicon, a Johnson & Johnson subsidiary, and CR Bard Inc.
In 2011, the FDA said the risks of side effects from transvaginal mesh products were no longer considered to be rare and that, in fact, there is a significant risk associated with the use of the surgical mesh. The new safety alert was preceded by a detailed review of scientific literature published from 1996 to 2011, which revealed unacceptable dangers associated with vaginal mesh. Scientific studies also showed there was no benefit to using TVM when compared with traditional treatments for POP and SUI.
A New England Journal of Medicine study indicates that women who received TVM implants suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage. TVM patients also had an increased number of adverse events after surgery, such as urinary incontinence and pain during intercourse.
By 2013, the FDA had ordered 95 postmarket (after implantation) studies by 34 manufacturers of surgical mesh used for POP and 14 postmarket studies by seven manufacturers of mini-slings for SUI.
According to the FDA, the most frequent complications related to TVM include:
- Erosion through the vagina
- Infection
- Pain, including pain during sexual intercourse
- Urinary problems
- Recurrence of the prolapse and/or incontinence.
Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.
In early 2014, the FDA was still considering whether to reclassify urogynecologic surgical mesh used for transvaginal repair of POP from Class II (low- to moderate-risk devices) to Class III (high-risk devices).
Manufacturer Responsibility for Transvaginal Mesh Problems
Strict liability rules, which apply in cases involving defective medical devices, allow manufacturers to be held liable if it can be proven that their product created unexpected risks or health issues for patients. Manufacturers may also be held responsible if they failed to warn patients of dangers, or if they knowingly released dangerous products onto the market.
TVM products were brought to market under special 510(k) rules that allow for fast-tracked FDA clearance based on similar medical devices that have already been approved. The 510(k) program enables manufacturers to bring products to the market with minimal testing.
Published reports also reveal that some manufacturers may have knowingly used a plastic material in the surgical mesh products that was not intended for use in the human body. Bloomberg reported in June 2013 that plaintiffs in a lawsuit against CR Bard have produced emails showing that executives may have engaged in intentional deception about the company’s use of resin plastic.
The CR Bard emails centered on the use of resin material made by Chevron Phillips Chemical Co., which had indicated that the plastic should not be surgically implanted for long-term use in humans. Despite this warning, a unit of CR Bard called Davol used the plastic in its hernia products. Plaintiffs who had TVM implanted argued that CR Bard also used the plastic in its transvaginal mesh products.
Emails from a top executive warned that suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” and went on to state, “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
Talk to Our South Carolina Lawyers About Defective Transvaginal Mesh Today
If you have suffered unexpected side effects from a transvaginal mesh product, you could have a valid claim against the manufacturer and be eligible for substantial financial compensation.
Talk to our attorneys at Joye Law Firm about your South Carolina TVM lawsuit for a fair and honest evaluation of your potential claim. Call Joye Law Firm now or use our online contact form for a free legal consultation.
Sources:
- Food and Drug Administration (FDA) – Surgical placement of mesh to repair pelvic organ prolapse poses risks
- FDA – FDA’s Role and Activities (urogynecologic surgical mesh devices)
- FDA – 510(k) Clearances
- The New England Journal of Medicine – Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse
- Bloomberg – Bard Used Mesh Plastic Found Unfit for Humans by Supplier
- FDA – Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence
