In 2008 and 2009, the FDA issued warnings to physicians that Transvaginal Mesh was linked to a list of complications months and even years after women had received the surgical mesh to correct pelvic organ prolapse or incontinence. These complications include infection, recurrence of prolapse, recurrence of incontinence, and organ or blood vessel perforation. Sometimes, these complications are life threatening.
The most frequently reported complication is vaginal mesh erosion. This complication is very painful because the mesh causes splitting of the skin, which increases the risk of infection. Pelvic organ prolapse can also return, which was, in many cases, what the mesh was meant to repair in the first place.
Vaginal Mesh Erosion
It was in 2009 when a clinical trial was conducted on Transvaginal Mesh that had to be abruptly stopped. Before the trial was even finished, 15% of the women had experienced vaginal mesh erosion within three months of the trial starting. As for risk factors that these women shared that led to the erosion, there were no common factors except for the fact they had received the mesh, but so had the remaining 85%. Ultimately, 15% is too high of a risk to take because most complications in clinical trials do not typically occur in more than 1% to 2% of the trial participants. If they do, the product usually does not reach the market. In this case, the mesh had already been on the market.
In 2011, the FDA issued a public notice to physicians that from January 2009 to December of 2010, 2,875 injuries had been reported in addition to those reported between 2005 and 2009. These reports involved nine manufacturers.
FDA Recommendations For Women
The FDA issued a set of recommendations for women after having Transvaginal Mesh implanted. Those recommendations say:
- Patients should maintain their schedule of routine checkups so that complications can be caught before they come very severe
- Patients should notify their doctor if symptoms of complications come about, such as vaginal bleeding, groin pain, pelvic pain, painful sex, or incontinence
- Patients should always let physicians know that they have the mesh
- Patients should address their concerns with their doctor and ask any necessary questions
- Patients should ask if mesh was used in their prolapsed pelvic organ surgery if unsure of what the surgery entailed
If you are a recipient of Transvaginal Mesh and you are experiencing complications, you will need to contact your doctor immediately. Bleeding and dangerous infection can occur, so it is best to have any pain addressed as soon as possible.
Transvaginal Mesh Lawsuits
Because of the complications associated with Transvaginal Mesh, lawsuits have and are being filed against the manufacturers for compensation relating to the damages. The complications can cause lifelong consequences and a compromised quality of life. Women that have undergone the surgery have done so to improve their quality of life, but what is happening is the post surgery problems are worse than those before the surgery and sometimes result in several surgeries to correct. To learn of your rights and options, call to schedule your free case evaluation at 1-800-732-3070.