FDA Notification Highlights Dangers Of Transvaginal Mesh, Attorneys Say
An updated Public Health Notification by the FDA—released July 13, 2011—regarding the possibility of serious health complications caused by transvaginal placement of surgical mesh has helped bring the problems allegedly caused by these medical devices into the public eye said speakers during the HB Litigation Conferences “Transvaginal Mesh Litigation Update” on Aug. 16, 2011.
“It’s an enormously condemnatory document,” said Fred Thompson, III of Motley Rice. The FDA advisory was an update to an earlier 2008 health update on Transvaginal Mesh (TVM), which stated that although adverse events were found associated with the devices, such events were rare.
“The new report shows that this device is not as efficacious as originally thought and that it’s no better than traditional means in dealing with [Pelvic Organ Prolapse] POP and [Stress Urinary Incontinence] SUI,” said Thompson.
POP and SUI are both associated with childbirth and pregnancy and are also caused by aging, said Vance Andrus of Andrus, Hood & Wagstaff, speaking at the conference. He said that both of these issues are very common.
“You would be astounded by the number of POPs and SUI surgeries that are done in the U.S. on regular basis,” said Andrus.
“TVM is transplanted to support the pelvic floor and in effect, it acts as a hammock to support the affected organs. TVM is just a form of surgical mesh and surgical mesh is either a metallic or polymeric screen which is intended to be implanted to reinforce soft tissue or bone where weakness exists,” said Andrus.
Andrus said that mesh was first used in the 1950s to repair hernias. In the 1970s gynecologists began using surgical mesh products for abdominal repair or pelvic organ prolapse. It wasn’t until the 1990s that it was inserted transvaginally.
“In order to do that the surgeons were required to take the mesh, which came in sheets, and cut it to the appropriate size and the appropriate shape and then place it into the surgical incision,” said Andrus.
Surgical Mesh Kits
“As the manufacturers detected a desire and a demand for new products they started developing surgical mesh patches specifically for repair of SUI and POP. By 1996 the FDA had cleared the first surgical mesh products specifically for use in SUI and in 2002 they had done the same for POP. Over the next few years the manufacturers started including tools to aid in the delivery. These surgical mesh kits continued to evolve adding new insertion tools, tissue fixation devices and anchors, surgical techniques and absorbable and biologic materials,” said Andrus.
Andrus said that the surgical mesh products are commonly made of synthetic polypropylene materials, but can also be made of biologic materials such as porcine collagen, or a combination of both synthetic and biologic materials.
“So what’s the problem? The problem is quite frankly that this material is neither safe nor effective,” said Andrus.
Douglass Kreis of Aylstock, Witkin, Kreis & Overholtz stated that the transvaginal mesh products on the market today never went through the FDA’s Pre-Market Approval (PMA) process and instead were “piggybacked”—via the FDA’s 510-K process—on other approved products, including the Protogen Vaginal Sling, which was subject to recall in 1999 and was the subject of numerous lawsuits.
Henry Garrard, III of Blasingame, Burch, Garrard, Ashley, PC, who is lead counsel of the Avaulta TVM Multi-District Litigation (MDL) in the Southern District of West Virginia, stated that complications occur when the mesh materials begin to degrade in the body.
“When it degrades it creates some more inflammatory processes. When you get a more inflammatory process, you get certain chemicals that are released by the body that again have a negative effect on the material—so it’s a never-ending cycle,” said Garrard.
Garrard said that he is “delighted” about the recent FDA notification.
“It’s a good step in the right direction—but be aware, what the companies are going to try to do is take that notification and say ‘Gosh, it’s really not a product problem. It’s really a problem of doctor training … they’re not adequately trained and they shouldn’t be doing this,’” said Garrard.
“The answer to this is, ‘You’ve unleashed this product onto all of the doctors—irrespective of how good or how bad they are—through your marketing scheme. Therefore you should have responsibility as well,’” said Garrard.
Fred Thompson said that he often sees the TVM companies launch an “aggressive defense” in which they put the “entire life history of the client under a microscope” in order to identify potential confounding factors for the clients’ symptoms.
“This injury is an area of great intimacy and it’s going to take a tremendous amount of support by the attorney to match the courage of the client in coming forward with these issues, because the defense is going to be bringing forward all kinds of confounders,” he said.
Thompson said that plaintiff attorneys should be “very happy” about the recent FDA report and the fact that the TVM products were not originally subject to PMA.
“One of the things you cannot get away from here is that this entire industry, this entire products is built on” the FDA’s 510-K process. He said that under the standard set forth in Riegel v. Medtronic, Inc. (No. 06-179; 451 F. 3d 104, affirmed.), if the products had received pre-market approval, any claims involving injury would have been preempted.