If you or a loved one had transvaginal mesh surgery, you may be eligible for compensation from the manufacturer. Call Ken Guin Attorney at Law, P.C. at 205-282-4500 or contact him online to schedule your free initial consultation. The United States Food and Drug Administration (FDA) has issued a statement that serious complications associated with the surgical mesh used in transvaginal placement can occur. In addition, the FDA has warned that transvaginal mesh may not be more effective in certain situations than non-mesh repairs and that it may expose patients to a greater risk of adverse side effects.
What is Vaginal Mesh or Transvaginal Mesh?
Transvaginal mesh is a medical device used to repair weakened or damaged tissue and placed through the vagina. It is made from either porous or non-porous absorbable synthetic material or absorbable biologic material. Transvaginal mesh is used to repair pelvic organ prolapse (POP) by being permanently implanted to reinforce the weakened vaginal wall or used to treat stress urinary incontinence. (SUI)
Pelvic Organ Prolapse occurs when the pelvic floor can no longer support the pelvic organs including the vagina, cervix, uterus, bladder, urethra, and rectum. The muscles and tissue of the pelvic floor may weaken with age or as a result of labor or childbirth. Other causes of POP are obesity, frequent constipation, or genetics. Symptoms of POP include pelvic pain, pressure, and bulging of tissue or organs.
Stress Urinary Incontinence is the most common type of urinary incontinence for women. They will experience urine leakage during physical activity or when coughing or sneezing. SUI occurs when the pelvic muscles supporting the bladder and urethra become weakened. This weakness can be caused by pregnancy, childbirth, aging, obesity, or pelvic surgery.
There have been thousands of reports of complications associated with the use of transvaginal mesh to repair POP and SUI. As a result, the FDA conducted a review to evaluate the safety and effectiveness of transvaginal mesh. The review has shown that using transvaginal mesh for POP is no better than non-mesh repair. They are still evaluating the results for SUI transvaginal mesh surgeries due to the high volume of incidents.
In 2011, the FDA began an investigation of the risks of transvaginal mesh implants, due to many of the following complaints:
· Mesh Erosion through the Vagina
· Pain during Intercourse
· Organ Perforation
· Uninary Problems
· Recurrent Prolapse
· Neuro-Muscular Problems
· Vagainal Scarring/Shrinkage
· Emotional Problems
In June 2012 a Major Manufacturer Discontinued Production of their Transvaginal Mesh Products
On June 2, 2012, Ethicon, a major manufacturer of Transvaginal Mesh discontinued production of the Gynecare TVT Secur and the Gynecare Prolift Pelvic Floor Repair Meshes.
The Four Issues Revealed by the FDA Review On Transvaginal Mesh
- Transvaginal mesh POP repair increases patient risks not found in traditional non-mesh POP repair.
- Transvaginal mesh surgery carries a higher risk of mesh complications than abdominal mesh surgery for POP repair.
- There is no evidence that using transvaginal mesh to support either the top or back wall of the vagina has any benefit to the patient over non-mesh treatment.
- There may not be any better symptomatic results when using transvaginal mesh to strengthen tissue between the bladder and vagina compared to traditional non-mesh POP repair.
The most commonly identified reported complication from transvaginal mesh surgery is the erosion of mesh through the vagina. This may require multiple surgeries to attempt to repair with sometimes less than satisfactory results.
Another complication from the use of transvaginal mesh is mesh contraction (shrinkage). This can result in vaginal shortening, tightening, and pain. Both mesh erosion and mesh contraction may cause severe pelvic pain as well as interfere with the woman’s ability to engage in sexual intercourse.
What Are the Common Complications?
The most common transvaginal mesh complications are the following:
• Protrusion of mesh through the vagina
• Infection in the treated area
• Painful intercourse
• Perforated organs
• Difficulties urinating
These injuries can lead to neuro-muscular problems, scarring and emotional issues. In most cases, additional surgery is needed to attempt a repair of the damage done as a result of the original transvaginal mesh surgery.
What Action Should You Take if You Have Had Transvaginal Mesh Surgery
If you had a transvaginal mesh surgery with no complications, there is no need to take any action. However, if you like the thousands of women that have symptoms such as persistent vaginal bleeding, discharge, pelvic pain, or pain during sex, first contact your medical professional and then call Ken Guin an experienced transvaginal mesh lawsuit attorneys to see if you might have a valid claim against the manufacturer of your mesh. These complications from transvaginal mesh surgery are linked to several brands of mesh which may qualify you for a claim.
Your free consultation will help to determine whether or not you might have a strong claim for compensation. If you have had symptoms of mesh erosion or mesh contraction after your transvaginal mesh surgery, you may be advised to file a lawsuit. Ken Guin will advise you on your next step and work with you every step of the way.
Contact a highly qualified, experienced general practice law firm today.
Call Ken Guin Attorney at Law, P.C. at 205-282-4500 or contact him online to schedule your free initial consultation.