WHAT HAS THE FDA SAID ABOUT VAGINAL MESH
The United States Food and Drug Administration (FDA) first issued a safety communication in 2008 that discussed the increase in complications with vaginal mesh placement. Since that time, similar events have increased in number.
On July 13, 2011, the FDA issued another press release specifically stating that the use of vaginal mesh to repair prolapsed exposed women to more risks than other options available to doctors.
The FDA reviewed medical literature published in the last 15 years to compare the experience of women with mesh surgeries vs. those without non-mesh surgeries. The review suggested that the use of mesh increased the chance of additional complications when compared to the use of stitches alone.
The FDA stated that when considering the use of vaginal mesh for treatment, health care providers should:
- Attempt to treat pelvic organ prolapsed without mesh,
- Understand that use of the mesh is permanent, which could make future repairs more difficult and increase the patient's chance of complications (link here to complications page) and future surgeries,
- Consider whether implantation of the mesh could be performed abdominally rather than vaginally,
- Fully inform patients as to the intent to use mesh and as to the risks and benefits of vaginal prolapse repair with mesh.
Experts in gynecology and obstetrics will meet in September to discuss this risks associated with vaginal mesh, the clinical studies that may be necessary to determine these risks, and the FDA's future recommendation(s).
To read the entire July FDA press release, click here
WHAT CAN I DO IF I HAVE VAGINAL MESH?
- Continue with your annual and routine checkups with your doctor if you are having no problems.
- Contact you doctor with any questions you may have regarding vaginal mesh.
- Tell your doctor at once if you develop symptoms such as persistent vaginal bleeding or discharge, pelvic or groin pain, pain with sex or any other unusual pain.
- Let every doctor know that you have surgical mesh so they can take necessary precautions.
Contact a Vaginal Mesh Attorney About the Vaginal Mesh Lawsuit
If you or a loved one has experienced vaginal Mesh complications, please consult our attorneys for a no-cost consultation at 1-800-576-2550 or contact us online.
Our California medical device lawyers have a number of cases pending throughout the country and have been evaluating numerous other cases. We have the experience to prove your case and the compassion to understand the life altering effects of vaginal mesh complications daily life and activities.
