A new FDA study indicates that the transvaginal mesh used in female surgeries for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may cause permanent injury to women rather than benefiting them. The FDA said. "There are clear risks associated with the transvaginal placement of mesh to treat POP." The FDA report documents also show that serious injuries from the transvaginal mesh are "not rare" and complications associated with surgical mesh treatment of pelvic organ prolapse and stress urinary incontinence can have serious consequences. Surgeries for pelvic organ prolapse and stress urinary incontinence that were performed without using the mesh had better outcomes. Women whom have had the mesh implanted have also been burdened with multiple follow up surgeries .
Medical device manufacturers whom promoted these surgical mesh devices to doctors around the world for use in surgeries, failed to conduct sufficient clinical testing of these mesh products to insure that they were both safe and beneficial. A very dangerous aspect of these mesh assisted surgeries is that once the transvaginal mesh has been implanted, it is for the most part impossible to remove.
The lawsuits that we are filing are to prove that the manufacturing corporations were negligent in marketing the transvaginal mesh without proper clinical testing and without disclosing to the doctors or the women involved that these mesh products and mesh kits had a substantial risk of serious permanent painful injuries and offered no benefit in improved surgical outcomes over surgeries without using the mesh.
If your Surgical Mesh implant has caused you unusual pain, discomfort or injury, call Perdue Kidd & Vickery at (877-833-7475) and speak to a lawyer that can advise you on your legal rights and help you receive the compensation you deserve.
FDA Warns About Transvaginal Mesh Products - 2008 Alert
October 21, 2008 - Clinicians should receive specialized training for the transvaginal placement of mesh products and be vigilant for adverse events, the US Food and Drug Administration (FDA) warned yesterday in a news release.
Though rare, complications associated with surgical mesh treatment of pelvic organ prolapse and stress urinary incontinence can have serious consequences. During the last 3 years, 9 surgical mesh manufacturers have submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.
Although mesh placement procedures are considered to be minimally invasive, bowel, bladder, and blood vessel perforations have also been reported. In some cases, vaginal scarring and mesh erosion have led to significant discomfort and pain, significantly decreasing the patient's quality of life.
Many women have needed multiple corrective surgeries and vaginal or rectal reconstructive surgeries to treat problems created by these defective transvaginal mesh products - while still suffering the uncomfortable pelvic conditions that they had hoped would be treated.
FDA: Continuing Safety Concerns With Transvaginal Mesh - July 13, 2011
A dramatic increase in reports of adverse events over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) is a continuing serious safety concern, the US Food and Drug Administration (FDA) announced.
Serious complications associated with surgical mesh for POP procedures and stress urinary incontinence (SUI) are "not rare," the FDA said in an alert, noting a reversal from its 2008 alert that said they were. "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," the FDA said. "There are clear risks associated with the transvaginal placement of mesh to treat POP," said William Maisel, MD, MPH, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, in a news release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant - complete removal may not be possible and may not result in complete resolution of complications." In 2010, at least 100,000 POP repairs used surgical mesh. About 75,000 of these were transvaginal procedures. POP may develop in 30% to 50% of women in their lifetime, with 2% developing symptoms.
An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. Among the reports, 2874 were received in the last 3 years (January 1, 2008, to December 31, 2010), and included 1503 reports associated with POP repairs and 1371 associated with SUI repairs. The number of reports associated with POP repairs increased by more than 5-fold compared with the number of reports received in the previous 3 years (January 1, 2005, to December 31, 2007), according to the FDA. Between 2008 and 2010, 7 reported deaths were associated with POP repairs. Followup investigation revealed that 3 of the deaths were related to the mesh placement procedure (2 bowel perforations, 1 hemorrhage).
Recent News
9/8/11-FDA advisers urge closer scrutiny of pelvic mesh click here to read more.
9/8/11-FDA Panel Calls for Surgical Mesh Studies, click here to read more.
