Surgical Mesh Causes Serious Complications in Transvaginal Surgery

The Food and Drug Administration (FDA) has recently issued an update to its warning regarding surgical mesh used in vaginal surgeries. Worried that more women are being harmed than helped by this medical device, the FDA warns that serious complications associated with transvaginal mesh are now more common than previously thought.

In fact, the FDA saw an increase in the number of serious complications over a two year period, which caused grave concern. Since 2005, nearly 4,000 adverse events related to surgical mesh devices have been reported. Of those, the majority of the adverse events were reported between 2008 and 2010.

The FDA has made an unprecedented move in announcing that surgical mesh may be more risky to patients than just surgery alone.

On September 8th and 9th, the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee will meet to determine whether to conduct studies that would identify patients who would benefit from the mesh. Any study undertaken by the panel would take several years to complete.

What is surgical mesh?
Surgical mesh is typically made of a porous absorbable or non-absorbable, synthetic or biologic material used to repair weakened or damaged tissue, especially in women who have pelvic organ prolapse (POP), which is a weakening of the pelvic organs, or stress urinary incontinence (SUI), which causes urine leakage during physical activity.

In procedures to treat these conditions, the surgical mesh is permanently implanted in either the vaginal wall or abdomen to reinforce the weakened tissue. Removal of the mesh, once implanted can be difficult, if not impossible.

Health care experts estimate that anywhere between 30 and 50 percent of women will experience POP in their lifetime. In just the last year, 300,000 women underwent surgery to repair prolapsed organs. Surgical mesh was used in nearly 75,000 transvaginal surgeries. Although fewer than a dozen manufacturers make surgical mesh, there are more than 85 surgical mesh devices that have been approved by the FDA for use in U.S. patients.

I underwent a procedure in which surgical mesh was implanted. What are common symptoms of an adverse reaction to the mesh?
Most of the problems women have with surgical mesh occur within one year of the mesh being implanted. Complications that have been reported include erosion through the vagina, infection, pain, urinary problems, and recurrences of a prolaspe or incontinence.

Other symptoms of defective surgical mesh include discomfort and pain, especially during sexual intercourse. Injuries to nearby organs, such as the bowels, bladder, and blood vessels, may also occur.

The FDA is especially worried about erosion of the mesh through the vagina, which is the most commonly reported problem with surgical mesh. If this erosion occurs, multiple surgeries may be required to repair the area. In some cases, the mesh cannot be completely removed.

Another major complication is mesh contraction, which is a shrinking of the mesh. This risk was not identified until adverse reports were filed after the FDA's October 2008 statement.

Why is surgical mesh still being used?
Many of the surgical mesh devices currently on the market were approved through a streamlined process known as 510K, which has been used by the FDA since the 1970s to evaluate medical devices similar to those already cleared. Any low-risk devices, like surgical mesh, may be granted approval in as little as 90 days.

The Institute of Medicine (IOM) has asked the FDA to abandon this type of review and instead require manufacturers to prove that each product is both safe and effective. Currently, the FDA is soliciting comments on whether to abandon 510K review. The FDA has refused to withdraw surgical mesh from the market, because it believes some patients may still benefit from the device.

Meanwhile, medical device manufacturers have lobbied strenuously for the FDA and Congress to speed up the time it takes to approve a device, citing less strict European regulations.

How do I know if surgical mesh was used in my surgery?
Prior to your surgery, your surgeon should have told you that he/she would be implanting surgical mesh and should have informed you of the risks associated with using surgical mesh. But if you had POP surgery and are unsure whether mesh was used, you should ask your health care provider at your next scheduled visit.

If you have not yet had surgery to correct POP or SUI, there are a few questions you should ask your surgeon before having the surgery, including:

Will you be using mesh in my surgery?
Why am I a good candidate for the mesh?
What are the alternatives to surgical mesh?
What results have you had using this medical device on other patients?
What side effects are possible with this medical device, and when should I report them to you?
If a complication arises with the surgical mesh, what will be done to remedy the problem?

I've experienced problems after having a surgical mesh implant. What are my legal options?
If you have experienced any of the side effects listed above after having a surgical mesh implant, you deserve to know your legal rights. The experienced defective medical device attorneys at Van Wey Law may be able to help you. For more information about complications arising from transvaginal surgical mesh, call Dallas attorney Kay Van Wey today at 214-329-1350 or 1-800-489-5082.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

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