Doctors often use “vaginal sling” or “bladder sling” procedures to treat Pelvic Organ Prolapse (POP)–a condition in which a woman’s reproductive or pelvic organs fall into or through her vaginal opening–and Stress Urinary Incontinence (SUI)–a condition marked by the involuntary leakage of urine from a woman’s urethra during moments of physical stress. These operations are called “sling procedures” because the doctors performing them use surgical mesh to create a sling-like structure of support for a patient’s urethra, bladder, or some other organ.
Products Used in Mesh Procedures Are Often Called “Slings”
As vaginal sling and bladder sling procedures increased in popularity in the late 1990s, medical device companies began to develop and market mesh products in configurations designed specifically to treat POP and SUI. Boston Scientific’s ProteGen Sling was one such product. Cleared for marketing by the Food and Drug Administration (FDA) in 1997, the ProteGen Sling was “rushed to market for ﬁnancial reasons without adequate premarket clinical trials,” according to American Journal of Obstetrics & Gynecology. Boston Scientific voluntarily recalled the ProteGen Sling in 1999 after having received thousands of complaints.
In the early 2000s, doctors began treating women’s incontinence by employing a sling operation that became known as a Tension-Free Vaginal Tape or “TVT” procedure, or an “intravaginal slingplasty.” One of the sling products used for this procedure was ObTape, which hit the market in 2003 and was manufactured by Mentor Corporation (a company that was eventually taken over by Johnson & Johnson). ObTape consisted of “a nonwoven polypropylene mesh that was threaded underneath the uretha, through the vagina, and out through the obturator foramen,” according to the American Journal of Obstetrics & Gynecology.
Like the ProteGen Sling, ObTape was cleared for sale by the FDA “without clinical proof of its safety and efﬁcacy.” It, too, caused patients immeasurable harm. As a result, its manufacturer discontinued it in 2006.
Many Mesh Sling Products and Bladder Sling Products Remain on the Market
Many types of bladder slings and mesh slings are still legally being used by U.S. doctors to treat female incontinence. They are marketed under many names, including the following:
- Tension-free Transvaginal Tape (TVT): Also known as Gynecare TVT, this mesh product is manufactured by Johnson & Johnson, and has been used to treat more than 1.5 million women worldwide. Doctors implant Gynecare TVT by making two small incisions in the abdomen, just above the public bone. No sutures hold the tape in place. Gynecare TVT reportedly was approved by the FDA based on its similarity to Boston Scientific’s ProteGen Sling, which–as noted above–has since been recalled.
- Mini Slings: There are several mini mesh slings and bladder slings on the market, including one known as the MiniArc. Doctors put mini-slings in place by making incisions in the same places used for TVT implants. They make a small incision under the urethra and place the sling/tape there. A mini-sling is positioned at a less acute angle than the TVT sling.
- Monarc SPARC Sling: The SPARC sling treats urinary stress incontinence by using two curved, narrow-diameter needles and a self-fixating sling with a tension suture. The Sparc sling is similar to other tensionless vaginal tapes, but the needles are thinner and are inserted from the suprapubic area in a posterior direction and guided with a finger inserted through a small suburethral incision.
Victims of Many Brands of Bladder Slings and Mesh Slings Are Suing
Victims of injuries caused by mesh slings and bladder slings have filed lawsuits to obtain compensation for their injuries. Those victims include patients who have received implants of a type of sling that has been recalled, the Protegen Sling, and one type that’s been discontinued, ObTape.
Lawsuits have been filed by patients who have been implanted with the many bladder slings and mesh slings that are still on the market, too, however.
Whether or not the products they were implanted with have been recalled, women suffering from side effects are filing lawsuits against several sling manufacturers, including Johnson & Johnson and Boston Scientific.
As of February 2012, the Judicial Panel on Multidistrict Litigation has ordered all federal-level vaginal mesh lawsuits against four manufacturers consolidated into four multidistrict litigation (MDL) proceedings before the U.S. District Court for the Southern District of West Virginia. District Court Judge Joseph Goodwin is the presiding judge. The four companies involved are: C.R. Bard; American Medical Systems; Boston Scientific; and Ethicon. MDL allows parties whose cases share common opponents, facts, and legal issues to combine their cases for the pretrial phase only. Consolidation saves the parties’ and the judiciary’s time and resources while allowing plaintiffs the opportunity to recover an amount of compensation that corresponds to their injuries, unlike in a class action lawsuit, which provides a fixed award. At the end of the pretrial process, the parties select a handful of plaintiffs, whose cases are typical of all plaintiffs, to try their cases before juries in what are called “bellwether trials.” Bellwether trials allow the remaining plaintiffs and defendants to assess their cases and decide whether they should proceed to trial themselves or settle out of court. The first transvaginal mesh bellwether trial is scheduled to begin on February 15, 2013, against C.R. Bard.
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