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LAWSUITS NEWS & LEGAL INFORMATION

Transvaginal Mesh—The Past Five Years

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Washington, DCFrom 2011, the FDA has warned health professionals and the public that transvaginal mesh was associated with serious complications that were not rare, and recommended the mesh be bumped up from moderate to high risk. Almost five years later, the agency has reclassified mesh products designed and marketed for transvaginal treatment of POP to Class III “High Risk Devices,” which means more stringent regulatory requirements for the manufacturers.

Transvaginal mesh time frame: 2011-2016

2011

July: The FDA states that complications caused by transvaginal mesh devices are not rare, citing a dramatic increase in the number of adverse events reported between 2008 and 2010. (In 2008, the agency said in a public health notification that "Although rare, these complications [with TVM to treat POP and SUI] can have serious consequences.”) Here is the July 2011 FDA safety alert.

September: The FDA starts an advisory panel of pelvic surgeons to study and discuss transvaginal mesh products and recommend that the vaginal mesh be reclassified from a Class II device, requiring more tests. The FDA Advisory Obstetrics-Gynecology Devices Panel suggests that TVM implants be reclassified from moderate risk to high risk (Class III), which would mean that manufacturers would have to conduct studies based on human testing.

2012

The FDA orders 33 transvaginal mesh manufacturers to conduct 3-year post-market surveillance studies (“522 studies”) on the devices, to help the agency develop a better picture of the devices’ safety and effectiveness, focusing on stress urinary incontinence (SUI).

Mesh manufacturers face more than 650 lawsuits claiming mesh injuries. Lawsuits are filed against Johnson & Johnson, American Medical Systems, and Boston Scientific, and are centralized in the Southern District of West Virginia.

C.R. Bard is found negligent in its handling of TVM: it didn’t properly test the products (Avaulta) before putting them on the market. Johnson & Johnson’s Ethicon unit stops selling four lines of vaginal mesh devices and issues an Ethicon transvaginal mesh recall of its Gynecare line of TVM products, though the company maintains that the recall is not safety related.

More than 8,000 vaginal mesh lawsuits have been filed in federal and state courts. Three multidistrict litigations arising from transvaginal mesh cases are consolidated into one MDL.

2013

The FDA issues 95 study orders to a total of 34 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse (POP); and 14 post-market study orders to seven manufacturers of mini-slings for SUI.

Bellwether cases are resolved and settlements begin. Following a $2 million jury verdict against C.R. Bard, the company negotiates a settlement with an additional plaintiff.

With more than 8,000 transvaginal mesh implant claims in process, the first trial begins. Plaintiff claims 18 surgeries to correct problems associated with Johnson & Johnson’s transvaginal mesh product.

2014

The FDA proposes two orders for transvaginal mesh POP repair to address the risks involved. Once final, manufacturers will be required to provide clinical data in a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for transvaginal POP. If the orders are finalized and the mesh reclassified as a high-risk device, manufacturers will be required to submit a PMA (510k) application

November: Seven major TVM manufacturers are involved in an MDL in the U.S. District Court for the Southern District of West Virginia. Federal lawsuits are filed against American Medical Systems, Ethicon, Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic. According to the orders, the announced FDA actions only apply to mesh devices marketed for the transvaginal repair of POP. Surgical mesh devices for other indications, like SUI or abdominal repair of POP, are excluded.

2015

The jury’s first verdict against C.R. Bard, the manufacturer of Avaulta TVM, awards plaintiff damages of $3.6 million rather than a settlement.

Johnson & Johnson’s Ethicon trial is underway in a West Virginia federal court. The trial combines 37 cases as part of an MDL of more than 23,000 cases. Almost 80,000 lawsuits have been consolidated in six MDLs against a number of mesh manufacturers. Besides J&J, they are all working on settlements.

2016

The FDA announces that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the mesh devices.

The agency reclassifies transvaginal mesh products to treat POP only as Class III “High Risk Devices.” The FDA requires manufacturers to submit a PMA application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

Some advocacy groups, such as Public Citizen’s Health Research Group, criticize the FDA for allowing transvaginal mesh on the market. Based on the timeline for the new orders, devices that advocates say are potentially harmful will be able to stay on the market until at least 2018 - almost 10 years after serious complications with transvaginal mesh were first reported.

January: A jury awards one plaintiff $13.5 million in her transvaginal mesh lawsuit against Johnson & Johnson and its Ethicon subsidiary. (A plaintiff in December 2015 is awarded $12.5 million in her lawsuit.)

February: Johnson & Johnson settles between 2,000 to 3,000 TVM case of its 42,400 cases against the company with a $120 million settlement.

July 2018: Deadline for transvaginal mesh manufacturers to submit a PMA application for their devices.

READ ABOUT TRANSVAGINAL MESH LAWSUITS

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READER COMMENTS

Posted by

on
http://www.theherald.com.au/story/3779748/medical-mesh-concerns-raised/

Posted by

on
I am a retired nurse who has/is suffering greatly due to the implantation of a Coloplast TOT bladder sling in 2010. I had to have a revision in 2014 after exposed mesh came through the vaginal wall. My husband suffered a penile laceration during intercourse. I cannot begin to express how mentally traumatizing this has all been, nor the toll it has taken on me physically.
The fight is far from over.... as the "justice system" moves at a snails pace with thousands suffering because of it. I am outraged at greedy pharmaceutical companies, the worthless FDA, and doctors who were... and are still willing to use these chemical laced products that are known to break down and erode in the body!!

Watch out big pharma!! Thousands of us are banding together and we are coming after you to force your hand at paying us for our suffering.... and putting a STOP to the use of your disgusting, harmful products.
Perhaps we should also be going after the surgeons who bought into their BS from the beginning and used us as guinea pigs!

Where are you "FDA"??? Are you really going to do anything to protect the public??

Posted by

on
Let's be very truthful here . This vaginal mesh problems goes 20 to 30 years back . But it started off in AUSTRALIA, JAPAN ,CHINA ,EUROPE, then appeared in AMERICA. After getting Corporations like Chevron and Texaco to supply them with RESIN and FOOLING the FDA with MONEY so THAT THE AMERICAN GOVERNMENT WOULD ALSO INVEST IN SLAUGHTERING AND BUTCHERING WOMEN FOR PROFIT! !!!!!. well let's get these stories on the
TRUTH NOTHING BUT THE TRUTH SO HELP ME GOD !!!!!. IS WHAT OUR COURTS SAY BUT JUSTICE IS BLIND WHEN CORPORATIONS CAN AND TAKE YEARS TO PAY WOMEN THE NEW GUINEA PIGS THAT SUFFERS EVERY LIVING SECOND IN PAIN FROM VAGINAL MESH !!!!

FDA RECALL , FDA RECALLL, FDA RECALL, FDA RECALL

THANK YOU AMERICA YOU DO KNOW HOW TO STABLE WOMEN RIGHTS IN OUR BACK .

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