This so-called fast track to the ER, if you will, is properly known as 510(k) and was an attempt by the regulator to allow new products into the market without the normal basket of clinical trials and data, provided the devices were substantially similar to products already on the market and performing satisfactorily.
Proponents of the accelerated protocol argue that 510(k) succeeds in getting needed and desirable products—and their related benefit—to patients faster. Not surprisingly, manufacturers freed from the costly and time-consuming constraints of gathering data sing the protocol's praises.
"The use of surgical mesh has an established track record and the 510(k) process has really enabled good learning and medical advances in this field," said Matthew Johnson, a spokesman for J&J's Ethicon subsidiary, in comments published September 7 in The Wall Street Journal.
A spokesperson for Boston Scientific agreed. "Boston Scientific's first priority continues to be patient safety," said Denise Kaigler. "We believe in the strength of the 510(k) process."
To that point, a spokesperson for the FDA noted that the fast-track protocol was designed so that manufacturers could avoid "reinventing the wheel" when introducing a product substantially similar to one that's already out there.
And yet, that strategy appears to have bared ugly teeth the regulator didn't know existed at the time 510(k) was drafted—and the Bard mesh could be one example of an oft-emerging dark side.
Avaulta mesh has been increasingly used in recent years to treat a condition known as pelvic prolapse, a condition that is characterized by the dropping of organs such as the bladder, bowel or uterus into the pelvic area and protrude into the vagina. Pelvic prolapse is triggered by weak pelvic muscles and is thought to affect about half of women who have borne children.
The use of mesh has evolved to become the preferred alternative to using a woman's own tissue to affect a support for the drooping organs. What's more, the application of surgical mesh—historically used for hernia repair—has moved from invasive surgery to a less-invasive insertion through the vagina.
It is due to the existence of mesh indicated for hernia repair that TVM mesh was fast-tracked to market via the FDA's 510(k) protocol.
According to The Wall Street Journal, the FDA's own estimates put the number of transvaginal mesh (TVM) procedures at 75,000 in the US last year. Many of those TVM procedures would have involved Bard Avaulta mesh.
Doctors are fans of the product and proponents of the procedure. But there have been problems. Between 2008 and 2010, the FDA looked into about 1,500 reports of adverse events associated with TVM mesh. In some of those cases, according to The Wall Street Journal, the mesh shifted from its point of original placement or tightened. Burred edges of the mesh have been found to protrude into the vagina, causing pain and discomfort. Many patients have been forced to avoid sexual intercourse. Others are unable to sit or stand for long periods.
READ MORE BARD AVAULTA TVM LEGAL NEWS
Health advocates say that had TVM mesh such as Avaulta pelvic mesh been forced to undergo the same rigorous testing and clinical trials required of a new product, those deaths and many heartbreaking stories of pain and suffering may well have been prevented.
In July, the FDA updated a safety alert issued in 2008 to reflect the statement that use of TVM mesh for pelvic prolapse affords "no evidence of greater clinical benefit." That same month, the influential Institute of Medicine called for greater oversight and a complete overhaul of FDA's medical device approval protocol.
On September 8, the FDA expert panel recommended such heightened oversight be required for Bard Avaulta, among other manufacturers of TVM surgical mesh.