Drugs & Medical Devices
Pelvic Mesh
|
FDA will require pelvic mesh makers to undertake additional safety studies
New York City, Jan. 5, 2012 -- Producers of potentially dangerous implants designed to rectify the symptoms of pelvic organ prolapse and urinary stress incontinence have been told by the US Food & Drug Administration that they will be required to conduct studies on the risks their products pose.
Pelvic mesh implants, patches used to buttress the muscle floor of women’s abdominal cavities, have been found in recent years to lead in many cases to a variety of adverse outcomes: incontinence, erosion of the mesh, extrusion, infection, pain and other injuries.
The Jan. 4, 2012 FDA announcement requires 35 medical device manufacturers to conduct postmarket surveillance studies, which will entail observing women in whom the device was implanted for three years, documenting complications and other factors.
The future may also hold an upgraded risk classification for the pelvic mesh implants, meaning that the FDA would require manufacturers to conduct additional studies before marketing such devices. Currently, pelvic mesh products may be marketed and sold without undergoing such trials.
The FDA’s decision to implement additional safety studies was influenced by statistics showing that the number of adverse outcomes reported for the pelvic mesh implants has more than quintupled in recent years. At least 1,500 cases of medical complications were reported in the three-year period from 2008 to 2010, up from around 300 cases in the 2005-2007 period.
Well over 200,000 women received pelvic mesh implants in 2010.
Weitz & Luxenberg is working closely with medical professionals to track the risks associated with pelvic mesh devices. If you have questions or need advice regarding these devices, please use the resources on our website, and feel free to contact us by calling our client relations center or by filling out the form on this page.
see also:
2008 Advisory
Transvaginal surgical mesh patch injury cases | Weitz & LuxenbergWomen who suffered an injury caused by a transvaginal surgical mesh patch can obtain a free lawsuit review from Weitz & Luxenberg's attorneys
Warnings
Warnings about Gynecare TVT Mesh | Weitz & Luxenberg attorneysGynecare TVT mesh has been linked to serious post-surgical complications in women. Those affected can get a free lawsuit review from Weitz & Luxenberg
FDA News
Transvaginal Mesh Patch Injuries | Weitz & Luxenberg AttorneysFree defective medical device lawsuit is available for women who were injured after receiving a transvaginal mesh patch during pelvic organ surgery.
