Transvaginal mesh (TVM), a medical device used during during urogynecologic procedures, has been associated with serious health complications and countless class action lawsuits.
TVM, also known as bladder slings, is a mesh device made from non-absorbent synthetic material that is inserted transvaginally and used in procedures to treat Pelvic Organ Prolapse and Stress Urinary Incontinence.
Recent research by the U.S. Food and Drug Administration (FDA) has found that these surgical meshes can harm patients and put them at risk for serious side effects including:
- Severe pain
- Mesh erosion
- Additional surgeries
- Organ perforation
- Neuro-muscular problems
- Vaginal scarring
- Mesh contraction
- Vaginal shortening/shrinking
According to FDA reports, in 2010, approximately 300,000 women underwent surgical procedures in the United States to treat Pelvic Organ Prolapse (POP) and 260,000 women underwent surgical procedures to treat Stress Urinary Inontinence (SUI.) Surgical mesh was used in one out of three POP procedures and 80% of SUI procedures.
Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction due to TVM.
As a result of receiving thousands of reports regarding complications, the FDA issued Public Health Notification warnings to surgeons and patients once in 2008 and again in 2011.
The FDA is conducting extensive research and testing on urogynecologic surgical mesh devices developed by manufacturers such as: Johnson & Johnson, American Medical Systems, C.R. Bard, Boston Scientific, and Ethicon. These assessments are being done to further evaluate the safety, effectiveness and potential serious complications associated with these devices.
If you or a loved one have been harmed by complications with TVM application and are seeking legal representation, please call our office for a free consultation.