In 2001, the IVS Tunneler® (Tyco IVS), created by United States Surgical, a division of Tyco Healthcare (spun off as Covidien in 2007 and acquired by Medtronic in 2014), was introduced as the first U. S. Food and Drug Administration approved transvaginal mesh delivery system designed to treat patients with pelvic organ prolapse (POP) and stress urinary incontinence.
Tyco surgical mesh devices, manufactured and marketed by Covidien as pelvic floor repair kits, have been used in thousands of procedures. A Tyco IVS kit includes a disposable, single-use surgical tool comprised of a stainless steel introducer, blunt tip stylette, and a non-absorbable mesh strip. The introducer device (“Tunneler”) is used to implant the polypropylene mesh tape transvaginally and positioned to reinforce the weakened vaginal wall, or in procedures treating stress urinary incontinence, support the urethra. Covidien has manufactured, marketed, and sold a number of devices which are also sold by different companies, particularly C.R. Bard, inc. (Bard) under the names:
Covidien marketed vaginal slings as a minimally invasive way to restore pelvic anatomy without the risks of open abdominal surgery. Patients have reported side effects from vaginal mesh implants made by various manufacturers, including:
Patients who experience complications from a failed vaginal sling often require revision surgery to remove the defective product and multiple excision surgeries may not result in complete removal of the mesh. Tyco IVS mesh patients may be at greater risk for complications since the Tyco IVS mesh has smaller pores than other mesh products, which could potentially promote infection since some cells cannot pass through the smaller pores.
The FDA received more than 4,000 adverse event reports related to transvaginal mesh implants between 2005 and 2010. In 2008, the FDA issued a public health notification titled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.” In 2011, the FDA issued a Safety Communication and detailed white paper addressed to doctors and patients warning that the use of a mesh in POP surgeries increased complication risks without any symptomatic benefits over non-mesh operations. Mesh erosion or contraction was the most frequent complication cited in the FDA reports.….” The FDA advised doctors to “recognize that in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.”
Approximately 75,000 of the over 100,000 mesh product liability claims filed against seven mesh manufacturers are currently pending before Chief Judge Joseph R. Goodwin in Multidistrict Litigation No. 2187 established in 2012 in the U.S. District Court for the Southern District of West Virginia. Covidien is not named as a defendant in these cases but is named as a co-defendant in approximately 11,300 cases involving mesh products provided to Bard. In June 2015, Covidien announced it had agreed to settle some of the pending claims.