FDA Says that Doctors Should Avoid Use of Transvaginal Mesh
The U.S. Food and Drug Administration (FDA) has issued another alert concerning use of surgical mesh. In the release, the FDA urges medical professionals to avoid using transvaginal mesh in patients.
Brief History of Transvaginal Mesh Issues
Transvaginal mesh is a medical device used in patients suffering from pelvic organ prolapse (POP). POP is a medical condition which occurs when tissues holding the pelvic organs in place become weak or stretched. The condition can result in pelvic organs dropping into the vagina. Organs involved include the bladder, uterus, rectum and bowel.
While this mesh appears to be a viable solution to POP, the FDA reiterates the dangers associated with use of this medical device in its latest release. The most recent release shifts the FDAs original stance away from considering the likelihood of injuries associated with mesh to be rare. Instead, the FDA now recognizes injuries are not rare, and use of the device should be avoided.
Both the FDA and The American Congress of Obstetricians and Gynecologists call on practitioners to avoid use of the product. Recommendation of transvaginal mesh use to patients should only be considered if the benefits outweigh the many reported risks.
Medical Practitioners May be Held Liable for Use of Device
The occurrence of POP continues to grow; more than 350,000 women undergo surgery for the condition every year. Although transvaginal mesh was once seen as a viable option for correction, the rate of injury associated with the device has resulted in a shift away from use.
Alternatives are available. Medical professionals are well aware of the “continuing serious concern” expressed by the FDA. As a result, if a medical professional uses the device without informing a patient of the many involved risks, the doctor may likely be held liable for resulting injuries.
If injured, remedies are available to cover medical and rehabilitative costs as well as pain and suffering. It is important to contact an experienced personal injury attorney to better ensure that all your legal rights and remedies are protected moving forward.