IVS Tunneller/SurgiPro Mesh
Product description: The IVS Tunneller®, created by United States Surgical, a division of Tyco Healthcare (now Covidien), came on the market in 2001 as the first transvaginal mesh delivery system approved by the U.S. Food and Drug Administration for use in both pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repairs. The IVS Tunneller® is sold as a kit consisting of a disposable, single-use surgical tool comprised of a stainless steel introducer, plastic-tipped blunt stylette, and a strip of non-absorbable “SurgiPro” mesh. The “Tunneller” introducer device is used to place a polypropylene mesh tape (“SurgiPro”) into the vagina to strengthen and secure the weakened vaginal muscles.
FDA Issues Safety Warning About Transvaginal Mesh Complications
In October 2008, the U.S. Food and Drug Administration (“FDA”) issued a public health notification entitled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.” In the 2008 notification, the FDA states that it had received over 1,000 complaints of complications related to mesh products.
In early 2011, a study published in the Journal of Obstetrics and Gynecology Canada recommended that until there is more evidence regarding the safety of transvaginal mesh systems, doctors should view using mesh to repair pelvic organ prolapse to be “experimental and restricted to use in clinical trials.”
Then in July 2011, the FDA took the extraordinary step of issuing a Safety Communication addressed to doctors and patients entitled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” In this Safety Communication, the FDA explained that it “is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
In conjunction with the July 2011 Safety Communication, the FDA also released a detailed white paper. The FDA observes that the “number of [medical device reports for adverse events] associated with POP repairs [from January 1, 2008 to December 31, 2010] increased by 5-fold compared to the number of reports received in the previous three years (January 1, 2005-December 31, 2007). The FDA summarized its findings from its review of the adverse event reports and applicable scientific literature, stating that it “has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk. The FDA further said that “these products are associated with serious adverse events…. Compounding the concerns regarding adverse events are performance data that fail to demonstrate improved clinical benefit over traditional non-mesh repair….” The FDA advises doctors to “recognize that in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.”
Contact A SurgiPro Transvaginal Mesh Injury Lawyer Today
If you or a loved one is suffering complications from defective transvaginal surgical mesh such as SurgiPro mesh, turn to the experienced medical device attorneys at Blasingame, Burch, Garrard & Ashley, P.C.
Our mesh injury lawyers are familiar with the serious complications caused by transvaginal mesh products used for pelvic organ prolapse (POP) repair and treatment of stress urinary incontinence (SUI). We have taken transvaginal surgical mesh cases to trial and we have successfully resolved over one hundred transvaginal surgical mesh cases — more than any law firm in the nation.
We are proud of our role as advocates for women’s healthcare and our record of success in these cases. The surgical mesh lawyers at Blasingame, Burch, Garrard & Ashley, P.C. are available to answer your questions or provide a free case evaluation.
Call us toll-free at 877-312-1753 or use our online form. We have trained, experienced female consultants available to discuss your situation and circumstances confidentially.
