Transvaginal mesh (TVM) devices have been implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Also referred to as pelvic mesh implants, bladder slings or surgical mesh, TVM devices have been linked to some serious risks and complications, the worst of which can result in irreversible injuries and significant impacts on women’s quality of life.
If you or a loved one has been injured by a transvaginal mesh device, you can turn to Kingston Product Liability Attorneys Shafran & Rock, PLLC for aggressive legal advocacy and effective help pursuing compensation and justice.
Transvaginal Mesh Injuries
Transvaginal mesh devices and bladder slings are surgically implanted in women to reinforce pelvic organs when the trauma of childbirth (or other events) has substantially weakened the pelvic walls.
Although these devices can treat POP and SUI for some women, tens of thousands of women with these devices have reported developing some serious health complications, including (but not necessarily exclusive to):
- Mesh erosion through the vaginal epithelium (the vaginal walls)
- Perforation of the tissues, blood vessels and organs surrounding the mesh device (including bowel and bladder perforation)
- Vaginal scarring
- Recurring POP, SUI and other urinary problems
- Dyspareunia (pain during intercourse).
For these and other serious bladder mesh complications, women typically need to undergo at least one risky, invasive revision surgery to remove the mesh device. For some, multiple revision surgeries are needed to try to treat the damage caused by transvaginal mesh implants.
FDA Warnings about Transvaginal Mesh
The U.S. Food and Drug Administration (FDA) has issued a number of warnings about the risks and complications associated with TVM devices. The following provides an overview of the most significant and recent FDA actions taken in regards to vaginal mesh devices:
- Jan. 4, 2016 – The FDA reclassified surgical mesh devices, switching them from a “moderate-risk” class II device to a “high-risk” class III device. At this time, the FDA also ordered mesh manufacturers to “submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.”
- July 13, 2011 – The FDA issued an update to the 2008 vaginal mesh warning, noting that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair,” as the mesh devices “may expose patients to greater risk.” At that time, the FDA also explained that it was continuing to monitor adverse event reports associated with TVM devices in order to “assess and improve the safety and efficacy of urogynecologic mesh products.”
- Oct. 20, 2008 – The FDA issued a Public Health Notification and Additional Patient Information, warning the public about the “serious complications associated with surgical mesh” for the treatment of POP and SUI. At this time, the FDA noted that:
- It had received “over 1,000 reports from nine surgical mesh manufacturers” regarding TVM complications and injuries.
- “Although rare, these complications can have serious consequences.”
Contact a Kingston Personal Injury Attorneys Shafran & Rock, PLLC
If you or someone you love been has been harmed by a defective transvaginal mesh device or bladder sling, it is time to contact Kingston Personal Injury Attorneys Shafran & Rock, PLLC. For over 20 years, Howard Shafran and Charles N. Rock have been dedicated to pursuing justice and financial recovery for the victims of negligence, including those who have been harmed by defective, faulty or dangerous medical devices like transvaginal mesh slings.
To find out more about your best options for financial recovery, contact us today to schedule a free, no obligations initial consultation. You can set up this meeting by calling (845) 383-1170 or by emailing our firm via the contact form on this page. To ensure that you have the legal support you need as soon as possible, the Attorneys at Shafran & Rock, PLLC can meet you at your home or a hospital when needed.
From offices based in Kingston, New York, Shafran & Rock, PLLC provides the highest quality legal services to clients throughout the state of New York and the U.S.