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FDA: Serious Complications of Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
As recent as July 13, 2011 the FDA directed a serious alert to healthcare professionals in gynecology, urogynecology, general surgery, internal medicine, family practice and emergency medicine.
What is surgical mesh? Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
What does the July 13, 2011 alert warn? An updated safety communication warned healthcare providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options. More importantly, the warning said that with exposure to greater risk comes no evidence of greater clinical benefit or an improved quality of life.
What is Pelvic Organ Prolapse? Pelvic Organ Prolapse or POP occurs when the tissues that hold the pelvic organs in place become stretched or weakened. When these organs become weak they drop and bulge or prolapse into the vagina. While not life-threatening, women with POP frequently suffer pelvic discomfort and disruption of urinary, sexual, and defecating functions -- and an overall reduction in their quality of life.
What are symptoms?
- Pressure on your pelvis and vagina
- An annoying to distressing feeling that you havenít fully empted your bladder
- Recurring bladder infections
- A bulge that protrudes through your vaginal opening but may go away when you lie down
- Loss of urinary control especially after sneezing and laughing
- Urinary leakage and pain during sexual intercourse
Have you or a loved one been injured after transvaginal mesh surgery? If yes, please contact a transvaginal mesh medical device lawyer today for your complimentary no-obligation legal consultation. Letís determine if we can help you obtain a settlementyouíre your pain and suffering and medical expenses.