New Transvaginal Mesh Warning Issued By Joint Gynecological Advisory Committee
Bernstein Liebhard LLP endorses a November 21, 2011 Joint Committee Opinion issued by the American College of Obstetricians and Gynecologists (“ACOG”) and the American Urogynecologic Society (“AUGS”), recommending that the use of transvaginal mesh for the treatment of pelvic organ prolapse (“POP”) be limited to high-risk women for whom the benefit may justify the risk.* Additionally, the Joint Committee recommended that a national registry be created to track outcomes for all patients who receive transvaginal mesh implants. ACOG and AUGS reviewed several cases studies and randomized trials, which examined the nature and incidence of complications caused by transvaginal mesh when used to treat POP.** The Joint Committee found that recent reports indicate that nearly 20% of POP repairs involving transvaginal mesh may result in mesh erosion.
AUGS President, Matthew D. Barber, M.D., noted that “The incidence of POP continues to grow. . . More than 350,000 women undergo surgery for this condition each year.” In July, the U.S. Food and Drug Administration (“FDA”) issued a transvaginal mesh warning, advising patients and doctors to consider alternative treatments to transvaginal mesh.*** The Joint Committee recommendations echo the FDA warning. Former chair of ACOG’s Committee on Gynecologic Practice, Cheryl B. Iglesia, M.D., explained that complications resulting from transvaginal mesh often require corrective surgery, however “complete removal of the mesh may not be possible. For this reason, it’s important to understand that, in many cases, POP can be successfully treated without mesh and women and their doctors really need to weigh the risks and benefits before deciding on a course of action.”
In addition to reiterating that the use of vaginal mesh should be limited and alternative options considered, the Joint Committee remarked that there is “an urgent need for the development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.” The Joint Committee focused heavily on the need for continuous review of patient outcome rates, comparative trials, and the adoption of new mesh products and devices only with clinical long-term data evidencing safety and efficacy.
In response to these latest recommendations, Bernstein Liebhard LLP partner, Jeffrey S. Grand, who has been appointed Co-Liaison Counsel in the consolidated pelvic mesh litigation, In re Pelvic Mesh/Gynecare Litigation (No. 006339-10 (N.J. Super. Ct.)), pending in the Superior Court of New Jersey, Atlantic County, commented, “The Joint Committee’s recommendations affirm plaintiffs’ position in the Pelvic Mesh Litigation – that such procedures should be reserved as a last resort for high-risk individuals without other treatment options and that only the most experienced surgeons should be permitted to perform prolapse repair with synthetic mesh.”
In 2008, the FDA issued its first communication regarding the dangers associated with transvaginal mesh,**** and has since continued to review the safety of the devices. Since that time, Bernstein Liebhard LLP has provided a wealth of consumer information concerning transvaginal mesh on its website, www.consumerinjurylawyers.com. If you or a loved one underwent a surgical procedure and have been implanted with transvaginal mesh, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
**December 2011 Committee Opinion entitled, “Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse”
For more information about filing a transvaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at firstname.lastname@example.org.
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