The Vaginal Mesh was introduced in the mid-1990’s. The transvaginal mesh was originally considered a major breakthrough for the treatment of pelvic organ prolapse (POP) occurring in women after childbirth, menopause, or hysterectomy. POP occurs when ligaments inside the pelvis or vaginal wall become stretched, making the uterus press on the bladder. This resulted in incontinence.The surgical mesh would relieve the resulting incontinence.Huge numbers patients who have been treated with the surgical mesh are facing devastating injuries as a result of erosion and decay of the mesh into their vaginal wall. As a result, women are facing not only multiple revision surgeries to correct the problem, but chronic pain and recurring infection.
Get Help Today
There has been an FDA Warning issued on the Transvaginal Mesh,
Surgical Mesh, Prolapse Mesh, and other Mesh products
On July 13, 2011, the FDA issued a press release stating that transvaginal placement of surgical mesh to treat POP may carry more risk than other surgical options. The administration warned that vaginal mesh had been conclusively linked to a number of adverse events including:
- erosion through the vaginal tissue
- pain during sexual intercourse
- urinary problems
- organ perforation from surgical tools used in the placement procedure.
These side effects are resulting in additional surgeries,inability to sit, have sexual intercourse,drive,denial of enjoyments of life and severe physical and emotional complications.
In 2010 alone, there were more than 100,000 POP repairs conducted involving surgical mesh devices.
Current News September 2011
Pelvic mesh safety concerns lead to September FDA panel meeting
The FDA has scheduled a fall meeting to shape future regulation surrounding transvaginal implantation of surgical mesh in treatment of pelvic organ prolapse on the heels of agency reports that the risks associated with the device may not be worth the benefits.
The FDA released a draft guidance yesterday warning that placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to unnecessary risk without offering clinical benefit above safer options.
The agency announced a forthcoming meeting to be held September 8 and 9, 2011, to consider the risks and benefits of the mesh as used for POP in light of adverse events, and to consider the treatment as an option for urinary incontinence.
The FDA is considering regulatory changes that may improve our understanding of the safety and effectiveness of this device.
A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
we have attorneys in: Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. CA; Oakland CA; Palm Springs CA; Palmdale CA; Redding CA; Sacramento CA; San Diego CA; San Fernando Valley CA; San Francisco CA; San Gabriel Valley CA; San Jose CA; San Luis Obispo CA; San Mateo CA; Santa Barbara CA; Santa Cruz CA; Santa Maria CA; Siskiyou CA; Stockton CA; Susanville CA; Ventura CA; Visalia CA; Boulder CO; CO Springs CO; Denver CO; Fort Collins CO; Pueblo CO; Rockies CO; Western Slope CO; Eastern CT CT; Hartford CT; New Haven CT; Northwest CT CT; Wilmington DE; Dover DE; Newark DE; Pike Creek DE; Bear DE; Washington D.C. District of Columbia; Daytona FL; Fort Myers FL; Ft Lauderdale FL; Gainesville FL; Jacksonville FL; Keys FL; Lakeland FL; Miami FL; Ocala FL; Orlando FL; Panama City FL; Pensacola FL; Sarasota FL; Space Coast FL; St. Augustine FL; Tallahassee FL; Tampa FL; Treasure Coast FL; West Palm Beach FL; Albany GA; Athens GA; Atlanta GA; Augusta GA; Brunswick GA; Columbus GA; Macon GA; Northwest GA GA; Savannah GA; Statesboro GA; Valdosta GA; Big Island HI; Honolulu HI; Kauai HI; Maui HI; Boise ID; East ID ID; Lewiston ID; Twin Falls ID; Bloomington IL; Carbondale IL; Chambana IL; Chicago IL; Decatur IL; La Salle County IL; Mattoon IL; Peoria IL; Rockford IL; Springfield IL; Western IL IL; Bloomington IN; Evansville IN; Ft Wayne IN; INpolis IN; Kokomo IN; Lafayette IN; Muncie IN; Richmond IN; South Bend IN; Terre Haute IN; Cedar Rapids IA; Des Moines IA; Dubuque IA; Fort Dodge IA; IA City IA; Mason City IA; Ottumwa IA; Quad Cities IA; Sioux City IA; Waterloo IA; Lawrence KS; Manhattan KS; Topeka KS; Wichita KS; Bowling Green KY; Eastern KY KY; Lexington KY; Louisville KY; Owensboro KY; Western KY KY; Baton Rouge LA; Lafayette LA; Lake Charles LA; Monroe LA; New Orleans LA; Shreveport LA; Portland ME; Lewiston ME; Bangor ME; West Scarborough ME; Annapolis MD; Baltimore MD; Cumberland Valley MD; Eastern Shore MD; Frederick MD; Western MD MD; Boston Massachusetts; Cape Cod Massachusetts; South Coast Massachusetts; Springfield Massachusetts; Worcester Massachusetts; Ann Arbor MI; Battle Creek MI; Central MI MI; Detroit MI; Flint MI; Grand Rapids MI; Holland MI; Jackson MI; Kalamazoo MI; Lansing MI; Monroe MI; Muskegon MI; Northern MI MI; Port Huron MI; Saginaw MI; Southwest MI MI; Upper Peninsula MI; Duluth MN; Mankato MN; Minneapolis MN; St Paul MN; Rochester MN; St. Cloud MN; Biloxi MS; Hattiesburg MS; Jackson MS; Meridian MS; Natchez MS; North MS MS; Columbia/Jeff City MO; Joplin MO; Kansas City MO; Kirksville MO; Lake of the Ozarks MO; Southeast MO MO; Springfield MO; St. Joseph MO; St. Louis MO; Billings MT; Missoula MT; Great Falls MT; Bozeman MT; Butte MT; Grand Island NE; Lincoln NE; North Platte NE; Omaha NE; Scottsbluff NE; Las Vegas NV; Reno NV; Manchester NH; Nashua NH; East Concord NH; Concord NH; Derry Village NH; Central Jersey NJ; Jersey Shore NJ; North Jersey NJ; South Jersey NJ; Albuquerque New Mexico; Santa Fe New Mexico; Albany NY; Binghamton NY; Buffalo NY; Catskills NY; Chautauqua NY; Elmira NY; Finger Lakes NY; Glens Falls NY; Hudson Valley NY; Ithaca NY; Long Island NY; New York City NY; Oneonta NY; Plattsburgh NY; Potsdam NY; Rochester NY; Syracuse NY; Twin Tiers NY; Utica NY; Watertown NY; Westchester NY; Asheville NC; Boone NC; Charlotte NC; Eastern NC; Fayetteville NC; Greensboro NC; Hickory NC; Outer Banks NC; Raleigh NC; Wilmington NC; Winston Salem NC; Fargo ND; Akron OH; Canton OH; Ashtabula OH; Athens OH; Chillicothe OH; Cincinnati OH; Cleveland OH; Columbus OH; Dayton OH; Huntington/Ashland OH; Lima/Findlay OH; Mansfield OH; Sandusky OH; Toledo OH; Tuscarawas County OH; Youngstown OH; Zanesville/Cambridge OH; Lawton OK; OK City OK; Stillwater OK; Tulsa OK; Bend OR; Corvallis OR; East OR OR; Eugene OR; Medford OR; OR Coast OR; Portland OR; Roseburg OR; Salem OR; Allentown PA; Altoona PA; Cumberland Valley PA; Erie PA; Harrisburg PA; Lancaster PA; Meadville PA; Philadelphia PA; Pittsburgh PA; Poconos PA; Reading PA; Scranton PA; State College PA; Williamsport PA; York PA; Providence RI; Warwick RI; Cranston RI; Pawtucket RI; East Providence RI; Woonsocket RI; Charleston SC; Columbia SC; Florence SC; Greenville SC; Hilton Head SC; Myrtle Beach SC; Sioux Falls SD; Rapid City SD; Aberdeen SD; Chattanooga TN; Knoxville TN; Memphis TN; Nashville TN; Tri-cities TN; Abilene TX; Amarillo TX; Austin TX; Beaumont TX; Brownsville TX; College Station TX; Corpus Christi TX; Dallas TX; Denton TX; El Paso TX; Fort Worth TX; Galveston TX; Houston TX; Huntsville TX; Killeen TX; Laredo TX; Lubbock TX; Mcallen TX; Odessa TX; San Antonio TX; San Marcos TX; Texarkana TX; Texoma TX; Tyler TX; Victoria TX; Waco TX; Wichita Falls TX; Logan UT; Ogden UT; Provo UT; Salt Lake City UT; St. George UT; Burlington VT; Essex Junction VT; Bennington VT; Charlottesville VA; Chesapeake VA; Danville VA; Fredericksburg VA; Hampton VA; Harrisonburg VA; Lynchburg VA; New River Valley VA; Newport News VA; Norfolk VA; Portsmouth VA; Richmond VA; Roanoke VA; SouthWV VA; Suffolk VA; VA Beach VA; Bellingham WA; Everett WA; Moses Lake WA; Olympia WA; Pullman WA; Seattle WA; Spokane WA; Tacoma WA; Tri-cities WA; Wenatchee WA; Yakima WA; Charleston WV; Huntington WV; Martinsburg WV; Morgantown WV; Parkersburg WV; Southern WV WV; Wheeling WV; Appleton WI; Eau Claire WI; Green Bay WI; Janesville WI; La Crosse WI; Madison WI; Milwaukee WI; Racine WI; Sheboygan WI; Wausau WI; Cheyenne WY; Casper WY; Laramie WY; Gillette WY;