On the heels of a Dallas jury ordering Johnson & Johnson to pay compensatory
damages as a result of a design flaw in their product, the U.S. Food and
Drug Administration (FDA) has made a call for stricter safety regulations
regarding the transvaginal mesh device.
In April, Johnson & Johnson, one of several manufacturers of transvaginal
mesh (TVM) implants, was ordered by a jury in Dallas to pay $1.2 million
to a woman injured when her TVM eroded inside her. Thousands of patients
have been subjected to additional and corrective surgeries because of
malfunctioning implants. Despite many reported issues with the mechanically
cut TVT-O mesh, it and others such as the TVT-Secur and the TVT-Abrevo
are still being widely used. The Dallas verdict represents the first TVM
lawsuit which deals with a "bladder sling" rather than a pelvic
organ prolapse (POP) product, and is projected to set the standard for
As early as 2008, the FDA has had knowledge of issues with the TVM products
after receiving more than 1,000 reports of patients suffering complications
after having the devices implanted. They released a "Public Health
Notification" at that time, and issued an additional warning to women
in 2011 of an exceptional health risk associated with the mesh.
This week, the FDA issued a press release indicating explicit risks associated
with the mesh products and outlining plans to reduce those risks in an
effort to improve the safety and effectiveness of the mesh. Upon finalization
of the proposed changes, manufacturers must supply premarket clinical
test results showing that their product offers POP patients a reasonably
safe and effective treatment option. The proposal does not affect surgical
mesh products used for hernia repair.
The proposed changes come after years of lobbying from patient advocates
and victim support groups. Currently, about 60,000 TVM cases are outstanding
nationwide against several different manufacturers. Victims report a variety
of complications, including pain, infection, bleeding, and urinary incontinence.
The proposal would allow the FDA to classify the mesh products as a "high
risk" medical device.
National Defective Medical Device Lawyers
If you have suffered complications as a result of your transvaginal mesh
implant, you could have a case against the manufacturer. Call the defective
medical device lawyers at Golomb & Honik today for a consultation
and to learn about your legal options. Our goal is to get you the greatest
maximum recovery for your physical and emotional suffering.
To learn more about your legal options or to schedule a free consultation call the
Philadelphia product liability lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national defective medical device lawyers at Golomb & Honik have
successfully represented individuals in Philadelphia, Pennsylvania, New
Jersey, and throughout the United States.