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Boston Products Liability?: FDA Considering Tougher Review Process for Mesh Products

Last month, our Boston injury lawyers posted a blog notifying our readers that the Food and Drug Administration had put out a public notice warning that mesh products can cause serious injuries to women when surgically implanted in their vaginas. This medical device is used in procedures for treating Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). While the FDA had put out an advisory in 2008 warning that complications could arise, now the federal agency is saying that serious side effects from transvaginal mesh procedures actually aren’t rare. In fact, the federal agency is questioning whether these medical devices are actually safe. Last week, consumer advocacy group Public Citizen called on the FDA to recall all transvaginal mesh products.

So far, no recall has been issued. However, the FDA is now considering reclassifying mesh products used for treating pelvic prolapse to the category of Class III medical devices, which means that their manufacturers would not be able to fast track them through the 510(k) premarket approval program. Instead, transvaginal mesh products would have to undergo tougher testing first. Companies that make transvaginal mesh products include American Medical Systems, Sofradim, Boston Scientific, Mentor, Caldera, Johnson & Johnson, CR Bard, Inc., Gynecare, and Ethicon.

In addition to concern over complications from pelvic prolapse, including organ perforations, problems with sexual intercourse, bleeding, pain, recurring incidents of POP, and post-surgery complications, the FDA is now saying it is not sure that undergoing a transvaginal mesh procedure to repair POP offers added benefits than more traditional procedures to repair POP. Also, in the event that a patient suffers complications requiring that the mesh product be removed, this may require multiple surgeries and the process can be extremely painful and debilitating.

If you are someone who suffered health complications after undergoing a transvaginal mesh procedure you may have reason for filing a Boston products liability lawsuit against the medical device manufacturer.

Read the FDA’s executive summary (PDF)

Surgical Mesh in Pelvic Repair Procedures Should Be Recalled, Public Citizen Tells FDA, Public Citizen, August 25, 2011

More Blog Posts:

Defective Medical Device?: Transvaginal Mesh to Treat Pelvic Organ Prolapse May Cause Health Complications, Warns FDA, Boston Injury Lawyer Blog, July 15, 2011
Boston Products Liability: Defective Zimmer NexGen CR-Flex Knee Replacement Devices Can Cause Painful Injuries, Boston Injury Lawyer Blog, June 9, 2011
Boston Products Liability Lawsuits Filed Over DePuy ASR Hip Devices, Boston Injury Lawyer Blog, January 4, 2011