J&J Vaginal Mesh Sold For Three Years In U.S. Before Receiving FDA Approval
An alarming report from Bloomberg News on March 21, 2012 revealed that certain Johnson & Johnson (“J&J”) vaginal mesh implants were sold for three years before receiving approval by the U.S. Food and Drug Administration (“FDA”). The J&J vaginal mesh implant at issue is the Gynecare Prolift, which was introduced in March 2005. The Gynecare Prolift was touted in the company’s annual report as an “innovative and effective surgical option” for women with weakened pelvic muscles. But it wasn’t until 2007 that the FDA realized that the J&J vaginal mesh was being sold without approval by the agency. The discovery came to light when J&J sought approval for a related transvaginal surgical mesh product, called the Prolift+M. The Prolift+M was based on a predicate version of a J&J vaginal mesh, which should have been submitted for FDA approval before being sold on the market. According to an FDA spokeswoman, the J&J vaginal mesh implants were distributed “without appropriate” clearance.
This is especially worrisome considering the number of vaginal mesh problems that have surfaced:
- In a July 2011 FDA report, there was a fivefold jump in deaths, injuries and other complications related to vaginal mesh for prolapsed organs, many of which were caused by J&J vaginal mesh implant products.
- A review of the FDA’s database indicates that there were a total of 123 complaints of vaginal mesh problems from the Prolift device between 2005 and May 15, 2008, when the device was finally cleared.
Vaginal Mesh Problems Lead To Hundreds Of J&J Vaginal Mesh Lawsuits
These J&J vaginal mesh implants are now the subject of more than 550 lawsuits filed by women who suffered vaginal mesh problems from surgical mesh implants. J&J is embroiled in litigation litigation over the vaginal mesh implants in New Jersey state court. To date, J&J has produced more than 2.3 million pages of documents and more than 70 company executives are expected to be deposed. The sworn testimony from these depositions as well as the company documents will prove to be important evidence as the litigation proceeds.
Bernstein Liebhard LLP partner Jeffrey S. Grand, who is serving as co-liaison counsel in the New Jersey transvaginal surgical mesh lawsuits against J&J and C.R. Bard, another medical device manufacturer, commented on this latest development: “This is symptomatic of a broken system where a manufacturer can unilaterally decide to put medical devices on the market without the FDA’s knowledge or approval.”
Experienced Vaginal Mesh Problems? Find A Lawyer Today
If you’ve experienced vaginal mesh problems after receiving a J&J vaginal mesh implant, you may be entitled to compensation for your medical expenses, pain and suffering, lost wages and other injuries. To learn more about filing a vaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP for a free case review. Our lawyers and staff understand the sensitive nature of vaginal mesh problems and can answer your questions in a caring and sympathetic manner.