FDA: Transvaginal Mesh (Mesh, Pelvic Mesh and Bladder Sling) Linked to Serious Side Effects
After experiencing a pelvic organ prolapse (POP) or suffering from stress urinary incontinence (SUI), you thought surgery would fix the problem. However, for thousands of women across the country, instead of getting better, they suffered serious, painful and sometimes permanent complications as a result of the transvaginal mesh used in their surgery.
If you or a loved one underwent surgery to repair a pelvic organ prolapse (POP) or stress urinary incontinence (SUI) and suffered complications linked to your mesh implant, you have legal rights! Contact the medical device lawyers at George Sink Injury lawyers today at 1-877-627-6625 or submit a web contact form.
We’ve helped over 35,000 injury victims get the justice they deserve, put our legal experience to work for you!
Problems with Transvaginal Mesh Implants
Tranvaginal mesh, also known as pelvic mesh, mesh or a bladder sling, is used to repair weakened or damaged tissue. According to the FDA, serious adverse events linked to transvaginal mesh are not rare. In fact, having a mesh surgery may increase your risk for needing additional surgeries due to mesh-related complications. For some victims, repeat surgery may not be able to resolve complications, making them permanent and life-altering.
In 2010, over 500,000 American women underwent surgery to repair either pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Of these surgeries, approximately 1 out of 3 POP procedures used mesh. Of these, 3 out of 4 surgeries implanted the mesh transvaginally. Of the SUI procedures, 80% were done transvaginally with mesh. As the popularity of using transvaginal mesh in POP and SUI repair surgery has increased, so has the number of serious and dangerous complications.
Side Effects Linked to Transvaginal Mesh
The following are the most common potential side effects linked to transvaginal mesh implants:
- Vaginal mesh erosion (also called exposure, extrusion or protrusion)
- Pain (including painful sexual intercourse, urination and defecation), pain may continue despite removal of the mesh
- Urinary problems
- Organ perforation
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
- Need for additional surgeries
- Loss of enjoyment of life
According to the FDA, data gathered from 110 studies that included nearly 12,000 women, showed that approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.
Based on evaluation of adverse event reports and assessment of the scientific literature, the FDA has NOT seen conclusive evidence that using transvaginally placed mesh improves clinical outcomes over surgeries that do not use mesh, and it may expose patients to greater risk.
Types of Transvaginal Mesh
Transvaginal mesh materials are divided into four categories. These include:
- Non-absorbable synthetic (e.g., polypropylene or polyester)
- Absorbable synthetic (e.g., poly(lactic-co-glycolic acid) or poly(caprolactone))
- Biologic (e.g., acellular collagen derived from bovine or porcine sources)
- Composite (i.e., a combination of any of the previous three categories)
Additional Information for Transvaginal Mesh Victims
If you underwent a transvaginal mesh implant surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI), notify your doctor immediately if you develop new or worsening symptoms, including, but not limited to:
- Persistent vaginal bleeding or discharge
- Pelvic or groin pain
- Pain during sexual intercourse
- Pain during urination or defecation
- Pain that persists after your last follow-up appointment
Legal Help for Victims of Transvaginal Mesh
Complications from surgically-implanted transvaginal mesh can be serious, painful and permanent. Constant pain, discomfort or the need for additional surgeries can burden you and your family. Don’t suffer alone, you may be owed financial compensation for medical bills, pain and suffering and other damages linked to your transvaginal mesh implant. Contact the medical device lawyers at George Sink Injury Lawyers at 1-877-627-6625 or submit a web contact form now. Our caring legal staff is standing by to help you.