cantthinkofanything
09-07-2011, 12:44 PM
http://www.bloomberg.com/news/2011-09-07/j-j-s-vaginal-mesh-to-be-weighed-by-fda-advisory-panel-as-lawsuits-climb.html
By David Voreacos and Alex Nussbaum - Sep 7, 2011 10:43 AM CT
J&J Vaginal Mesh Faces FDA Panel as Number of Lawsuits Rise
Daniel Acker/Bloomberg
Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois, U.S., on Monday, April 11, 2011.
Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois, U.S., on Monday, April 11, 2011. Photographer: Daniel Acker/Bloomberg
Marci Sutin Levin says U.S. regulators failed her by not requiring extensive testing before allowing Johnson & Johnson (JNJ) (http://www.bloomberg.com/apps/quote?ticker=JNJ:US) to sell the type of surgical mesh implanted in her in 2007.
The U.S. Food and Drug Administration (http://topics.bloomberg.com/food-and-drug-administration/) used an abbreviated process known as 510(k) to clear the mesh, which supports weakened muscles that can’t hold a woman’s pelvic organs in place. Levin, a 65-year-old New York marketing executive, endures pain so intense that she can’t work, sleep through the night or have sex with her husband, she said. Levin said the endless pain hurts worse than natural childbirth.
“The pain of childbirth was finite, and you’re delivering a child,” Levin said in an interview. “This was very, very different. It’s relentless, and it’s untenable. And it doesn’t lead to anything.”
Levin filed one of about 270 lawsuits pending against J&J, based in New Brunswick (http://topics.bloomberg.com/new-brunswick/), New Jersey. C.R. Bard Inc., of Murray Hill, New Jersey, and other mesh makers also face litigation around the U.S. About 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse.
The FDA warned (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm) July 13 of a rise in injuries related to the mesh, and it said last month the devices should be reclassified from moderate risk to high risk, a change that would typically require new clinical data.
By David Voreacos and Alex Nussbaum - Sep 7, 2011 10:43 AM CT
J&J Vaginal Mesh Faces FDA Panel as Number of Lawsuits Rise
Daniel Acker/Bloomberg
Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois, U.S., on Monday, April 11, 2011.
Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois, U.S., on Monday, April 11, 2011. Photographer: Daniel Acker/Bloomberg
Marci Sutin Levin says U.S. regulators failed her by not requiring extensive testing before allowing Johnson & Johnson (JNJ) (http://www.bloomberg.com/apps/quote?ticker=JNJ:US) to sell the type of surgical mesh implanted in her in 2007.
The U.S. Food and Drug Administration (http://topics.bloomberg.com/food-and-drug-administration/) used an abbreviated process known as 510(k) to clear the mesh, which supports weakened muscles that can’t hold a woman’s pelvic organs in place. Levin, a 65-year-old New York marketing executive, endures pain so intense that she can’t work, sleep through the night or have sex with her husband, she said. Levin said the endless pain hurts worse than natural childbirth.
“The pain of childbirth was finite, and you’re delivering a child,” Levin said in an interview. “This was very, very different. It’s relentless, and it’s untenable. And it doesn’t lead to anything.”
Levin filed one of about 270 lawsuits pending against J&J, based in New Brunswick (http://topics.bloomberg.com/new-brunswick/), New Jersey. C.R. Bard Inc., of Murray Hill, New Jersey, and other mesh makers also face litigation around the U.S. About 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse.
The FDA warned (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm) July 13 of a rise in injuries related to the mesh, and it said last month the devices should be reclassified from moderate risk to high risk, a change that would typically require new clinical data.