Transvaginal mesh complications
Transvaginal mesh (“TVM”) is a net-like implant used to treat women who suffer from pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”), which are conditions that generally develop after a hysterectomy, menopause or childbirth.
Since TVM was first introduced into the U.S. market over 20 years ago, millions of women have undergone the procedure. However, in October 2008, the FDA issued a Public Health Notification that informed clinicians and patients of the risks associated with TVM after receiving over 1,000 adverse event reports. The FDA issued another warning in 2011 following receipt of over 1,500 adverse event reports associated with mesh used for POP repair—five times as many as the agency received from 2005 to 2007. The FDA concluded that serious complications from TVM products were not rare.
Plaintiffs in the lawsuits involving at least seven different manufacturers of the device assert that as a result of being implanted with TVM, they experienced mesh contraction and mesh erosion causing severe pain, vaginal scarring, infection, urinary problems, sexual dysfunction and perforations of the bowel, which often require one or more revision surgeries. In addition, men have asserted derivative claims for loss of consortium.