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Transvaginal Mesh Claims / Lawsuits / Recall Information In the 1990’s the use of surgical mesh became common in transvaginal repair procedures for pelvic organ prolapsed and stress urinary incontinence. It was thought that the procedure offered a minimally invasive alternative for traditional surgeries. Recent research from the FDA shows that these procedures may have serious side effects for patients such as mesh erosion, additional surgeries (revision surgeries), pain – sometimes very serious pain - , and even death. DrugRxRecall and The Mulligan Law Firm is currently evaluating potential transvaginal mesh induced claims originating in all 50 states. VAGINAL MESH: WHAT YOU NEED TO KNOW Pelvic Organ Prolapse (POP) occurs when the muscles and tissues around the pelvic organs stretch and/or weaken. This then can cause the organs to bulge into the vaginal wall. Stress Urinary incontinence takes place when there is a leakage of urine during times of physical activity. This can include relatively simple activities such as sneezing, coughing, laughing, or light exercise, not to mention more strenuous forms of exercise. Vaginal mesh products are one item used to treat SUI and POP. The FDA first cleared a product for surgical mesh treatment of SUI in 1996. The FDA cleared the first mesh product for POP procedures in 2002. In POP repairs, the mesh is placed through small incision points made in the vaginal wall. This is where the word “transvaginal” originates. This operation is intended to reinforce the weakened vaginal wall and help support the bulging organs. In SUI repairs, the mesh is used as a sling device to support the urethra. Approximately 300,000 women underwent surgeries to repair POP according to the FDA. About 260,000 underwent SUI repair procedures. About 1/3 of POP surgeries used mesh products and about ¾ of the mesh POP operations were performed transvaginally. About 80% of SUI repairs were done with transvaginal mesh products. Sadly for many patients, in both 2011 and 2008 the FDA warned of the possible adverse side effects of surgically implanted transvaginal mesh products. At the time of writing this, the FDA has received in excess of 3,850 reports from patients of death, malfunction, and injury due to transvaginal mesh procedures. Due to the serious nature of these injuries, we encourage patients who have suffered with these devices to contact our lawyers as soon as possible. One of the most common complications of these devices includes erosion of the mesh through the vagina. This is also sometimes known as exposure, extrusion, and/or protrusion of the device. Other symptoms of complications include, but are not limited to, dyspareunia, infection, pain, urinary problems, organ perforation, and bleeding. There are also reports of incontinence, prolapse, vaginal scarring, neuro-muscular damage and problems, vaginal shrinkage, and emotional problems such as depression. Many of these issues often require hospitalization and more revision surgeries. Some women have had to have even more than a dozen revision surgeries. Various Examples of Side Effects of Transvaginal Mesh Products Include Potentially: · Vaginal shortening and/or shrinking · Infection · Bleeding · Erosion through the vagina · Organ perforation of the bowel, blood vessel, or bladder · Additional revision surgeries · Painful sexual intercourse (dyspareunia) · Severe pelvic vaginal pain · Inability to engage in sexual intercourse · Neuro-muscular issues · Recurrence of prolapsed and/or incontinence · Vaginal scarring · Mesh contraction Types of Transvaginal Mesh In general, mesh product materials can be sorted into four types: · Absorbable synthetic materials · Biological materials such as acellular collagen derived from porcine or bovine sources · Non-absorbable synthetic materials such as polyester and /or polypropylene · Composites that can include mixes of any of the above three types The most common type of mesh product used in transvaginal surgeries is the non-absorbable synthetic polypropylene type. The mesh is often cut to match the organ defect type that it is specifically meant to address. What is Pelvic Organ Prolapse (POP)? Pelvic Organ Prolapse or “POP” takes place when the tissue around he pelvic organs becomes weakened or stretched, sometimes from childbirth. Commonly associated with pregnancy, it can also occur even in women who have never had children. POP causes organs including the bladder, bowel, uterus, rectum, and top of the vagina to bulge into the vagina. Sometimes more than one organ may prolapsed at one time and the can also prolapsed past the vaginal organ. POP is known by other names such as dropped bladder, dropped vagina, dropped uterus, dropped rectum, rectocele, enterocele, and cystocele. Somewhere around 30 – 50 % of women may experience POP during their lifetimes, but only 2% will observe symptoms. The majority of cases can be treated with exercise as well as vaginal inserts known as pessaries. Overall women have about an 11 percent lifetime incidence of having POP or SUI repaired through surgical methods. Surgical repair can be done abdominally and/or transvaginally. Some symptoms of POP can include vaginal lumps, difficulty emptying the bowel or bladder, problems with sexual intercourse and/or constipation. Some factors that doctors think may contribute to the development of POP include menopause, smoking, family history, pelvic trauma, smoking, multiple vaginal deliveries, diabetes, previous surgeries, and some connective tissue disorders. If you or a loved one observe any of these potential symptoms described in this article, make sure to discuss your concerns /condition with your licensed physician.
What is SUI (Stress Urinary Incontinence)?
Stress urinary incontinence affects somewhere around 20-40 percent of women. SUI is suspected when there is leakage of urine during exercise, laughing, coughing, and other physical activities including sneezing. SUI can sometimes be treated with exercise, and is also surgically repaired at times either abdominally or transvaginally. When treated transvaginally, a synthetic sling is placed under the urethra to stop urinary loss during physical activities. Who are Synthetic Mesh Manufacturers? The FDA has identified some of the manufacturers mentioned in reports of post-surgical transvaginal mesh complications, and these include: · Johnson & Johnson · Boston Scientific Corp. · Cook · American Medical Systems · Covidien · CR Bard Additionally, complaints have been made about products manufacturered by General Medical Devices, Ethicon, Inc., Caldera Medical, and Endo Pharmaceuticals. The FDA Warning On October 20, 2008 the FDA released a Public Health Notification warning patients and doctors of over 1,000 complications associated with transvaginal placement of surgical mesh in repair of SUI and POP. The FDA stated at that time that the complications were reported in rare cases. The FDA reported that the most commonly reported side effect was erosion through the vaginal wall, and other complications included urinary problems, pain, recurrence, organ perforation and scarring. The FDA stated that cases of scarring and vaginal erosion caused a decrease in patient quality of life and suffering including inability to have sexual intercourse (dyspareunia). The notification recommended that surgeons obtain specialized training on mesh placement, be very vigilant about adverse side effects, watch for complications, warn patients about potential complications and remind them that the implant placement is permanent. On July 13, 2011 the FDA updated its 2008 Public health Notification with a Safety Communication. At this time the FDA reported that complications were not rare. The FDA also reported that the complications may be life-altering. In addition to the 1,000 reports of complications / side effects reported prior to the 2008 notification, the FDA received over 2,800 additional reports of injury, malfunction, and death. Over 1,500 were associated with POP repairs. 1,371 were connected to SUI repairs. There were also deaths reported connected to POP repairs. Several deaths were linked with mesh placement procedures. The FDA also reported that patients who received transvaginal mesh products were at a greater risk of complications compared to patients who received traditional non – mesh procedures / products. Synthetic mesh vaginal products / procedures had risks not present in other non-mesh surgeries. The FDA also reported that transvaginal POP repair does not probably provide any benefit compared to traditional surgeries without mesh. FDA also reported a risk of mesh contraction / shrinkage. This is associated with vaginal shortening, tightening and pain. What Type of Transvaginal Mesh Products Have Been Sold in the United States? Some of the manufacturers and sellers of transvaginal mesh products include Mentor Worldwide, LLC, C.R. Bard, Inc., American Medical Systems, Johnson & Johnson (and J&J’s subsidiary, Ethicon, Inc.), Boston Scientific Corp., and Covidien PLC (including subsidiaries Tyco Healthcare, Sofradim Production, and Tissue Science Laboratories). C.R. Bard, Inc. transvaginal mesh products (many of which are designed and / or created by a subsidiary of Covidien PLC) include, but may not be limited to: · Avaulta BioSynthetic Support System · Avaulta Plus BioSynthetic Support System · Avaulta Solo Synthetic Support System · Align · Perfix Plug · Uretex · Pelvilace · Pelvisoft · Pelvicol · Pelvitex American Medical Systems transvaginal mesh products include: Apogee, Perigee, Monarc, MiniArc, IN-Fast, BioArc, Elevate, Sparc. Transvaginal mesh products designed and/or manufactured by Tyco Healthcare include: IVS-02, IVS Tunneller / Surgipro. Boston Scientific Transvaginal Mesh products include: Pinnacle, Uphold, Solyx, Prefyx, Lynx, Obtryx, Advantage, Advantage Fit. Johnson & Johnson through Ethicon, Inc. transvaginal meshes: Prosima, Gynemesh, Gynemesh PS, Prolift, Prolift M, TVT, TVT-O, TVT Exact, TVT Secur, TVT Abbrevo, TVT Retropubic System. If you believe that you or a loved one is suffering from complications from a transvaginal mesh product, including any Bard product or Avaulta product, call us today for a free claim evaluation. We have women intake professionals trained to help with your issue that will return your contact promptly.
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