Pelvic organ prolapse and stress urinary incontinence are two conditions that many women suffer from. Pelvic organ prolapse (POP) occurs when the organs in the pelvis, such as the bladder, the uterus, the urethra or the small bowel prolapse or drop out of their normal place and start to push against your vagina. Stress urinary incontinence, on the other hand, refers to difficulty preventing involuntary urination, especially when you cough or laugh. Both conditions occur when the muscles become weak, and are a common consequence of childbirth, although aging and other factors can also play a role.
Many women who suffer from POP or stress urinary incontinence thought they had found an answer in transvaginal mesh (TMV). More than nine manufacturers released various transvaginal mesh products, which were surgically implanted and used to keep organs in place. Women throughout the country had operations with transvaginal mesh. Unfortunately, problems soon came to light.
Today, physicians still use TVM as a method of treating POP and stress urinary incontinence. Unfortunately, the dangers of these products have increasingly come to light. Our Boston injury attorneys want to make sure that every woman is aware of the risks of transvaginal mesh before making the choice to take a chance on using this treatment method.
The History of Transvaginal Mesh Complications
Transvaginal mesh began causing complications for women shortly after it became a widespread treatment option. In October of 2008, the FDA issued a warning indicating that they had received more than 1,000 complaints of adverse events related to TVM. When the FDA released this initial report, it described the complications as “rare.”
Despite the complaints and the increasing number of women experiencing serious infection, recurrence of prolapse and other medical problems, physicians continued to use TVM products for treatment of POP and stress urinary incontinence.
Unfortunately, from January 1, 2008 to December 31, 2010, the TVM continued to create serious health problems for women. The FDA received 2,874 new complaints of adverse events during this time. The problems were occurring both when the mesh was used to repair POP (1,503 complaints) and when the mesh was used to repair SUI (1,371 complaints).
The frequency of the complaints and the reports of serious complications prompted the FDA to conduct a systematic review of the scientific literature that was published from 1996 to 2011 that related to the TVM products. The FDA made some upsetting determinations when doing this review. It noted, for example, that using TVM to repair POP did not significantly improve the results or the woman’s quality of life as compared to other traditional treatment methods. The scientific literature also revealed that there were risks of using the TVM that did not exist with traditional treatment methods.
In July of 2011, the FDA updated its communications to warn that complications were not rare and to let women and physicians know that TVM can expose patients to significant risk.
Every patient needs to be aware of the new FDA position and of the fact that complications are very common. If your physician recommends that you treat your POP or stress urinary incontinence with TVM, you need to consider the danger carefully and have a detailed discussion with your physician about why this risk is acceptable given your medical condition and the other treatment options available.
If you or a loved one has experienced TVM complications, contact the Law Offices of Jeffrey S. Glassman, LLC for a free consultation. Call 1-877-617-5333.