Thousands of lawsuits across the nation have been filed by women and their families against Johnson and Johnson, one of the renowned manufacturers of transvaginal mesh products. The Lawsuits have similar allegations that the health care giant Johnson & Johnson have not disclose and mispresented the severe risks associated with transvaginal mesh implant and falsely marketing the device without adequate warning of it adverse effects. More than 70,000 lawsuits filed by women who were injured by mesh implantation. The lawsuits are pending in the U.S. District Court for the Southern District of West Virginia. Additional lawsuits are pending in state courts. The U.S. Food and Drug Administration this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for the company.
Vaginal mesh is a net-like implant also known as trans vaginal mesh, pelvic mesh, tape, or sling which is most commonly used to repair tears in the connective tissue of the pelvis, causing the intestines, bladder or bowel to protrude into the vagina. Vaginal mesh, trans vaginal tape, and trans vaginal slings are used to stitch the connective tissue in the vaginal wall muscle back together. Unfortunately, thousands of women have been seriously injured when their implant eroded into their vagina, perforated organs, caused chronic pain, or required revision surgery. Trans vaginal mesh is implanted through the vagina to support weakened, sagging pelvic muscles. There are mainly three types of surgical mesh implanted:
- Mini-sling – Implanted with a metallic inserter that aids in the alignment of the mesh close to the mid-urethra to help reduce the risks of cuts while being inserted. Mini-slings have only been used since 2006, so the long-term side effects are still being studied.
- The tension-free vaginal tape (TVT) sling – The traditional TVT slings require a retropubic surgical procedure with the insertion of polypropylene mesh tape through a vaginal incision and two incisions in the abdomen that allow for the passage of the sling underneath the urethra.
- The transobturator tape (TOT) sling – The procedure in which surgeons claims to have more control over tape placement. A subfascial hammock is formed under the urethra. This method reduces the risk of bladder injuries because the needle bypasses the retropubic area.
The above three procedures of mesh implantations are approved by FDA. Most GYN and female urology surgeries use the polyester or polypropylene type of mesh. The mesh is produced by several manufacturers and has been used in tens of thousands of surgical procedures in the United States. But TVM has been linked to serious health complications that can often require painful and invasive revision surgeries to correct. Though there are many manufacturers of transvaginal mesh devices, thus far companies named in current lawsuits include such notables as: American Medical Systems (AMS), a subsidiary of Endo, C.R. Bard, Cook Medical Inc., Boston Scientific, Coloplast Corp and Neomedic.
Adverse Events and Risks Associated with Pelvic Mesh
Transvaginal surgical mesh was intended to permanently repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and were approved specifically for SI use in 1996. But due to the design defects and the manufacturer’s negligence the device has contributed to serious events and complications such as organ perforation and tissue erosion. Thousands of lawsuits have been filed by women and their families against medical device manufacturers of transvaginal mesh products. The lawsuit alleges that the manufacturers are known of the risk and adverse events associated with the device. The complications include:
- Projection of the mesh through the soft tissues;
- Infections in the area of the mesh
- Urinary tract problems
- Perforated bladder, perforated bowel or perforated blood vessels
- Organ injuries
- Additional surgeries may be required and sometimes the problem still isn’t corrected; and
- Pain during intercourse.
FDA Guidance for Health Care Providers
- The provider should take Specialized training for each mesh placement technique, and be-aware of its risks.
- The provider should be cautious for adverse effects with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Patients should be notify by provider that mesh is permanent, once implanted it may not be possible to remove. The implanted mesh may require additional surgery that may or may not correct the complication.
- Patients should be Inform about the possibility of adverse effects on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
- The provider should be careful in most cases, mesh is not required and all complications can be avoided by not using it
- The provider should be careful about the patients that placing meshes transvaginally may higher the risk of complications when compared to abdominally
- The provider provides patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.
The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products. Thousand women have suffered from pain during intercourse, pelvic pain and several surgeries to remove the mesh and filed lawsuits against the manufacturers of concealing known risks, failing to warn about side effects, and continuing to market the mesh as safe and effective device. The plaintiffs accuse the company for manufacturing a defective medical device.
If you or somebody you know was injured or suffered complications or death from Transvaginal mesh, you may contact Drugsclaim.com for a free case consultation. All cases are pursued on a contingency fee basis there are never any out-of-pocket costs to hire our attorneys unless we win your case. The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs Lawsuits.