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FDA Wants Transvaginal Mesh Device Makers to Study Related Health Complications

December 31, 1969

At Howard Law, PC, our Orange County, California products liability represent patients that have been injured because of medical devices that were defective, failed, or faulty. One device, in particular, that has spurred hundreds of personal injury lawsuits in the US over the past few years is vaginal mesh, which has been used in hundreds of thousands procedures over the last few years as the implant device of choice for women suffering from pelvic organ prolapse and stress urinary incontinence.

Now, the Food and Drug Administration has written to 33 transvaginal mesh manufacturers telling them that they need to study the rates of health complications linked to these medical devices for a three-year duration. Johnson & Johnson, Boston Scientific, and C.R. Bard Inc. are three of the companies that received these letters, which come several months after the federal agency reported a significant jump in the number of injuries, deaths, and failures related to the mesh implants. The FDA also noted that it cannot verify whether using transvaginal mesh, as opposed to more traditional devices and procedures to treat the same ailments, presented more benefits.

Many of the women who reported related complications have had to undergo additional surgeries to remedy the damage done and/or remove the implant. In some cases, scar tissue that had developed made it impossible to remove the faulty device. Some patients have had to deal with chronic pain, organ damage, infection, urinary tract erosion, organ perforation, perineal cellulitis, painful intercourse, and other complications as a result of their vaginal mesh implants.

"It is important that medical devices are free from safety issues that can cause serious injury to patients," said Howard Law PC partner and Anaheim transvaginal mesh attorney Vincent Howard. "The number of injuries linked to mesh implants is unreasonably high and unacceptable."

The FDA received reports of 1503 adverse occurrences related to transvaginal mesh between 2008 and 2010. This was a fivefold increase from the two years prior.

"You want to work with an Orange County, California medical device manufacturer that isn't afraid to go up against large companies so that you can recover the compensation that you are owed," said Anaheim products liability attorney Vincent Howard.

Vaginal mesh products are FDA-approved under the 510(k) system, which allows medical devices that are similar to ones already approved to forego human testing. However, it is important to note that the majority of transvaginal mesh products that are FDA-approved under this system can trace their approvals to a mesh product made by Boston Scientific that was recalled 13 years ago.

The studies the FDA wants the 33 manufacturers to conduct will focus only on mesh products already available in the marketplace. One wonders why transvaginal mesh products that are not yet available shouldn't be studied before they are released into the market.


J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says, Bloomberg, January 5, 2012

FDA reevaluating vaginal mesh implants, Los Angeles Times, July 13, 2011


More Blog Posts:

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers, July 5, 2011

California Products Liability: Defective Hip Implant Devices Continue Causing Injuries, California Injury Lawyers, December 30, 2011

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers, August 22, 2011

To schedule your free case evaluation with Anaheim defective medical device attorney Vincent Howard, contact Howard Law, PC today.