icnmgrjill
06-13-2012, 09:17 AM
When the FDA and various patient rights groups starting talking about the complications that women had begun to experience after having surgery to repair their pelvic organ prolapse and/or urinary incontinence, we took note. Many IC'ers also struggle with pelvic organ prolapse, a weakening of the pelvic floor muscles that allows their bladder and/or uterus to drop... in some cases so severely that it can bulge out of the vaginal opening. Clearly, repairs must be made but the question is how.
Transvaginal mesh products were developed to fill this need. Made of a variety of materials by different companies, they were all the rage several years ago and hot topics at urology conferences around the world. It was subsequently surgically implanted in thousands of patients. But, over time, patients started experiencing problems... usually the deterioration of the skin around the mesh. Women (and their husbands) reported that they could feel it protruding through the vaginal wall. Mesh concentration, mesh shrinkage, chronic pain and infection were also reported and, unfortunately, surgical removal of the mesh can be extremely difficult.
After receiving thousands of complaints of adverse events, the US FDA released a warning in 0ct. 2008 to consumers and clinicians regarding serious complications experienced with MESH. That was revised in July 2011 leading to a two day meeting of the FDA's Obstetrics & Gynecology Devices Advisory Committee.
The FDA is now considering reclassifying mesh products from Class II to Class III devices which will require proof that the products are safe and effective. Similarly, earlier this year, the FDA ordered mesh manufacturers to conduct additional postmarket safety and surveillance studies.
Thus, it comes as no surprise that Ethicon Inc, a subsidiary of Johnson and Johnson has announced that it will stop selling several pelvic mesh products here in the USA. Patient advocates (and their attorneys) are rejoicing with the news.
Hundreds of lawsuits have been filed as a result of these complications with the first "bellwether trial" set for November of this year. Federal litigation is pending in the US District Court for the Southern District of West Virginia as well.
If you are a patient who has been harmed through the use of pelvic mesh surgery, please check this article below. You may have legal recourse for damages.
http://news.yahoo.com/j-js-decides-voluntarily-recall-transvaginal-mesh-products-170224491.html
Transvaginal mesh products were developed to fill this need. Made of a variety of materials by different companies, they were all the rage several years ago and hot topics at urology conferences around the world. It was subsequently surgically implanted in thousands of patients. But, over time, patients started experiencing problems... usually the deterioration of the skin around the mesh. Women (and their husbands) reported that they could feel it protruding through the vaginal wall. Mesh concentration, mesh shrinkage, chronic pain and infection were also reported and, unfortunately, surgical removal of the mesh can be extremely difficult.
After receiving thousands of complaints of adverse events, the US FDA released a warning in 0ct. 2008 to consumers and clinicians regarding serious complications experienced with MESH. That was revised in July 2011 leading to a two day meeting of the FDA's Obstetrics & Gynecology Devices Advisory Committee.
The FDA is now considering reclassifying mesh products from Class II to Class III devices which will require proof that the products are safe and effective. Similarly, earlier this year, the FDA ordered mesh manufacturers to conduct additional postmarket safety and surveillance studies.
Thus, it comes as no surprise that Ethicon Inc, a subsidiary of Johnson and Johnson has announced that it will stop selling several pelvic mesh products here in the USA. Patient advocates (and their attorneys) are rejoicing with the news.
Hundreds of lawsuits have been filed as a result of these complications with the first "bellwether trial" set for November of this year. Federal litigation is pending in the US District Court for the Southern District of West Virginia as well.
If you are a patient who has been harmed through the use of pelvic mesh surgery, please check this article below. You may have legal recourse for damages.
http://news.yahoo.com/j-js-decides-voluntarily-recall-transvaginal-mesh-products-170224491.html