FDA: Transvaginal Mesh Is More Harmful than Helpful. Are You at Risk?

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Did you have urogynecological mesh implanted to treat POP or SUI?

Surgical mesh is used to repair weakened or damaged tissue. While it has helped many, some uses of surgical mesh pose serious health risks. In July 2011, the U.S. Food and Drug Administration (FDA) warned that "surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options." To make matters worse, the FDA also noted that there is no evidence that this use of transvaginal mesh has any more benefits than other treatments.

The Medical Device & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on representing plaintiffs in transvaginal mesh lawsuits. Isaacs & Isaacs handles cases nationwide and are currently accepting new transvaginal mesh cases in all 50 states for claims against the following manufacturers and brand names of transvaginal mesh devices:

Johnson & Johnson	Pelvicol® Tissue
Ethicon TVT	PelviSoft® Biomesh
Gynecare TVT	Pelvitex™ Polypropylene Mesh
Gynemesh PS	American Medical Systems or AMS
Prolene Polypropylene Mesh Patch	SPARC®
Secur	Boston Scientific
Bard	Advantage™ Sling System
Avaulta Plus™ BioSynthetic Support System	Obtryx® Curved Single
Avaulta Solo™ Synthetic Support System	Obtryx® Mesh Sling
Faslata® Allograft	Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System

Isaacs & Isaacs handles cases involving all these manufacturers.

You may be entitled to compensation for your injuries and we can help.

Until this recall, transvaginal mesh was frequently used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Women who were injured or suspect they may have complications directly linked to POP or SUI surgery and/or the placement of a transvaginal mesh product, should contact Isaacs & Isaacs immediately. Our lawyers help women throughout the country get compensated for their transvaginal mesh injuries.

If you have had transvaginal mesh implants, talk to your doctor. Then talk to us.

Women who have already had surgery involving transvaginal mesh devices should immediately notify their doctors if they have any of the following symptoms:

Persistent vaginal bleeding or discharge	Vaginal infection and scarring
Pelvic or groin pain	Bowel, bladder, and blood vessel perforation from the mesh placement procedure
Pain with sex	Organ prolapse
Exposed or protruding vaginal mesh	Urinary problems

Women who have had transvaginal mesh implants are at risk for additional surgery to treat complications. In some women, however, repeat surgery will not eliminate the problems. Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

There are safer ways to treat POP and SUI. Don't let your doctor put you at risk.

Pelvic organ prolapse (POP) occurs when pelvic organs bulge into the vagina. This happens when the tissue that supports the pelvic organs (bladder, uterus, bowels) becomes weakened or stretched. POP can be very uncomfortable and cause urinary incontinence, but it is not a life-threatening condition. Doctors can repair POP surgically through the abdomen or the vagina. They can also use stitches or surgical mesh to make anatomical corrections.

In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures. Over the past three years, FDA has received more than 1,000 reports from women of injuries associated with surgical mesh used to repair POP and SUI.

Ask questions before you agree to transvaginal mesh implants.

Now, healthcare providers should know about the dangers of using transvaginal mesh, but not all do. The FDA recommends asking your doctor these questions prior to surgery:

• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
• If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• What if the mesh surgery doesn't correct my problem?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
• If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Since there are safer, more effective options available, you should avoid surgical solutions that include transvaginal mesh.

Choose Isaacs & Isaacs. Put our experience to work for you!

In addition to representing many consumers across the USA that were injured by other forms of defective mesh products, our attorneys are actively involved in investigations of transvaginal mesh products. We draw upon experience gained in other mesh and products liability litigations to appropriately investigate, evaluate, and pursue potential transvaginal mesh injury claims. Contact us for a FREE case review.