Posts Tagged ‘Transvaginal Mesh’

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

Sunday, March 25th, 2012

Read more: //www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5Io0Rjv

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally pl

aced pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

If you or anyone you know has been hurt by any pelvic mesh, call us at: 877 882 0095

Read more: //www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5J7lsqi

Injured Women Sue Johnson & Johnson Over Vaginal Mesh Product

Friday, October 21st, 2011

What was supposed to be a simple surgery to relieve bloating and constipation turned into a living nightmare for Linda Gross, 46, of Watertown, S.D.

Gross experienced pelvic organ prolapse, a condition in which the organs of the pelvis begin to shift because of a weakened pelvic wall. Her doctor implanted Gynecare Prolift, a relatively new type of surgical mesh, into her pelvic wall through incisions made in her vagina.

Ever since that implantation in 2006, Gross says she has had urinary complications, constant pain and swelling as her body continues to reject the mesh. She says she can’t sit for more than 20 minutes, she can’t have sex with her husband, she can’t be active for more than a few minutes at a time. Twelve surgeries have failed to remove all the mesh or relieve her pain and swelling.

If you or anyone you know has been hurt by any transvaginal mesh products, call us at: 877 882 0095

For original article see:

//abcnews.go.com/Health/WomensHealth/johnson-johnson-sued-vaginal-mesh-product/story?id=14473688

Report on Transvagainal Mesh Failures

Wednesday, October 19th, 2011

From MSNBC, a report on the failure of mesh implants

100,000 mesh patients in 2010 In 2010, the agency says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal. From 2005 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3,000 more.

If you or anyone you know has been hurt by any transvaginal mesh product, call us at 877 882 0095

Read more //www.msnbc.msn.com/id/43886793/ns/health-health_care/#.TpraaHJu5Rw

FDA Updated Warning on Transvaginal Mesh for Pelvic Organ Prolapse

Wednesday, October 12th, 2011

The FDA published an updated warning on the risk and serious complications that are associated with transvaginal placement of surgical mesh for pelvic organ prolapse (POP). The FDA indicated that POP occurs “when tissues that hold the pelvic organs in place become weak or stretched.” The original FDA Public Health Notification concerning these products was released on October 20, 2008. However, in October 2008, the FDA advised that the complications associated with these products were rare. According to the Updated Public Health Information published on July 13, 2011, the FDA has now concluded that these complications are in fact, Not Rare.

The FDA has made the following recommendations for patients with transvaginal mesh:

· Continue with your annual and other routine check-ups and follow-up care.

· Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex.

· Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.

· Talk to your health care provider about any questions you may have.

· If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.

If you or someone you know has been hurt by these transvaginal mesh products, call us at: 877 882 0095

For original article by Shayna Slater see:

//central-pennsylvania.injuryboard.com/miscellaneous/fda-updated-warning-on-transvaginal-mesh-for-pelvic-organ-prolapse.aspx?googleid=295042

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