Philadelphia Products Liability Lawyers Can Help Victims Suffering From Transvaginal Mesh Complications
June 18, 2012
By Debra A. Jensen, Esquire
A subsidiary of Johnson & Johnson, Ethicon Inc., announced last week that the company is discontinuing the sale of four of its transvaginal mesh implants. The company’s decision came as a result of many women across the country experiencing severe physical and emotional complications after the implantation of these defective medical devices. Moreover, there are currently over one thousand vaginal mesh product liability lawsuits pending against the company. The defective products that will be taken off the market include Gynecare Prosima Pelvic Floor Repair System, Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System, and Gynecare Prolift +M Pelvic Floor Repair System. The company is not recalling any of the devices that have already been implanted or sold.
Prior to the recent announcement, Ethicon, Inc. asked the United States Food and Drug Administration (FDA) for approval to halt their worldwide sales of the defective medical devices. The company requested 120 days to complete the process of notifying their customers and to guide them in pursuing different treatment options. In addition, despite the marketing halt of the defective products previously noted, Ethicon has asked to continue marketing the product Gyencare Gynemesh.
Complications Associated With the Defective Vaginal Mesh Implants
Transvaginal mesh implants have become increasingly common medical devices used to treat several medical conditions. They have been implanted in hundreds of thousands of women undergoing surgery to strengthen the pelvic wall and to provide support in pelvic organ prolapse cases. In addition, the mesh implants have been utilized in treating stress urinary incontinence.
The FDA has received numerous complaints citing adverse health consequences associated with the mesh implants. Serious complications that have been reported include pain, infections, urinary problems, bleeding, painful intercourse, organ perforation, mesh erosion, vaginal scarring, and vaginal shrinkage. Many women have required additional surgeries in an attempt to remove the mesh.
The FDA sent letters earlier this year to the manufacturers of the surgical mesh implants asking for new safety studies to be undertaken. As a result of the complaints, and the resulting safety studies, it is becoming increasingly clear that the mesh implants present an obvious and substantial risk of injury despite their medical value in some cases. Unless the manufacturers acknowledge the risk of serious injury and discontinue marketing the defective medical devices, they will continue to be accountable for product liability claims.
Vaginal Mesh Implant Sold Without FDA Clearance
Many of the vaginal mesh implants were approved for sale under the process known as 501(k), an FDA approval process for medical device products that has raised many concerns. Under the 510(k) device approval process, the FDA does not require new medical devices to undergo safety and effectiveness testing. A medical device only needs to be shown to be similar to a previously-approved device on the market already.
The Gnecare Prolift was initially sold in March 2005. Ethicon sold these surgical mesh implants for three years without obtaining any approval from the FDA. The FDA only learned about the product when it was cited during an approval request for another surgical mesh product. Both devices were given approval in 2008 and now are the subjects in numerous lawsuits. The FDA is now taking the position that that vaginal mesh implants may need to be reclassified under their system into a higher risk category that would require human clinical trials prior to being approved for sale
Philadelphia Product Liability Lawyers Can Help Victims Suffering From Transvaginal Mesh Complications
The Philadelphia product liability attorneys at Galfand Berger support Johnson & Johnson’s decision in stopping the sale of the defective transvaginal mesh implants. We understand that many women have suffered devastating, unbearable injuries and we believe that the manufacturers of these dangerous medical devices need to be held accountable. Our team of highly skilled and experienced personal injury lawyers has handled all types of defective medical product lawsuits and can help you recover compensation for your injuries, including medical expenses, lost income, and pain and suffering.
If you or a loved one has suffered personal injuries from complications associated with a vaginal mesh implant or any other defective medical device, we encourage you to seek the legal advice of an experienced Philadelphia product liability lawyer at Galfand Berger. Our offices are conveniently located in Philadelphia, Reading, and Bethlehem, Pennsylvania. Contact the Philadelphia product liability lawyers at Galfand Berger at 1-800-222-8792 to schedule a free and confidential consultation or submit a free online inquiry.