FDA Considers Next Step for Transvaginal Mesh, Medical Device Approvals

A Food and Drug Administration (FDA) advisory panel has recommended that some transvaginal mesh products be reclassified as the process for approving mesh and other medical devices comes under scrutiny.

On July 13, the FDA updated a 2008 public health notification, reporting that complications from transvaginal mesh are not rare and that it is not clear that transvaginal mesh surgery is more effective than non-mesh repair of pelvic organ prolapse (POP). Having received over 3,800 reports of complications, the FDA urged surgeons to consider other options before performing transvaginal mesh surgery.

Since then, more than 600 women have filed lawsuits over complications from transvaginal mesh, which is surgically implanted to treat both POP and stress urinary incontinence (SUI). POP occurs when a women’s pelvic muscles and organs are weakened and stretched, often after child birth or hysterectomies.

Women reported painful complications such as internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems. Corrective surgery is often required and is not always successful. In one report by Bloomberg News, a woman reported she had undergone 17 procedures to reverse damage from transvaginal mesh, including five surgeries, and is still suffering from the condition.

The FDA approved the first transvaginal mesh product, ProtoGen by Boston Scientific, in 1996. Two years later, Johnson & Johnson won approval for a similar device called Gynecare VT, but was not required to conduct human testing on it. Using the FDA’s 510(k) process for medical devices, Johnson & Johnson was allowed to bypass testing by claiming the device was “substantially equivalent” to the Boston Scientific mesh product.

The FDA approves 90 percent of medical devices under the 510(k) process, including defective hip implants and external heart defibrillators that have been subject to recalls in recent years.

Critics say the 510(k) process is flawed and needs to be overhauled. In the case of Boston Scientific, the Massachusetts manufacturer recalled its surgical mesh product in 1999 as other companies were just starting to bring their product to market. There are a total of nine manufacturers of transvaginal mesh products.

In January, the FDA announced it was considering 25 changes to the 510(k) system. In July, the non-profit U.S. Institute of Medicine issued a warning about it and Congress has pushed the FDA to make changes.

As for transvaginal mesh, the FDA convened an advisory panel to review the safety of the medical device in September. The 17-member panel recommended that some transvaginal mesh be reclassified as high-risk devices and require new studies be conducted to stay on the market. The FDA has yet to make a decision.
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FDA Issues Warning About Transvaginal Mesh Surgery

The Food and Drug Administration (FDA) has issued a public notice on transvaginal mesh surgery after receiving thousands of reports about harmful complications. The notice advised patients and healthcare providers to consider alternatives to mesh surgery. The FDA has not issued a product recall, but will convene a panel this fall to make recommendations for the procedure.

Transvaginal mesh is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These conditions can emerge after childbirth and pregnancy. POP occurs when organs bulge into the vaginal and bladder areas. SUI is a loss of bladder control.

Over 1,000 adverse events involving transvaginal mesh devices were reported to the FDA between 2005 and 2007. On October 20, 2008, the FDA issued a Public Health Notification reporting the figures. From January 2008 to December 31, 2010, there were an additional 2,874 reports of complications.

From 2006 to 2011, the FDA conducted a systematic review of published scientific literature and reported transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA is advising health care providers to only choose mesh surgery after carefully comparing the risks and benefits with other surgical options.

The most frequent complications associated with transvaginal mesh surgery is erosion throughout the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. There were also reports of emotional problems, vaginal scarring and neurovascular muscular problems.

Many of these conditions involve painful remedies, including medical treatment, several surgeries and hospitalization.

Several companies manufacture transvaginal mesh, including Johnson & Johnson and Boston Scientific, C.R. Bard, Tyco Covidian and AMS. Injuries have not been linked to a single brand of mesh.

If you have been injured by a transvaginal mesh repair, you may be entitled to compensation. It is important to speak to an experienced product liability lawyer as soon as possible so you can obtain the proper medical attention and compensation for your injuries, loss of time at work and pain and suffering.

For a free legal consultation, contact the experienced Boston product liability lawyers at Breakstone, White & Gluck today. Call us at 800-379-1244 or use our contact form.
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