What Reclassification of Vaginal Mesh Products Would Mean: A Thorough Analysis on ... Twitter?What Reclassification of Vaginal Mesh Products Would Mean: A Thorough Analysis on ... Twitter?

Could vaginal mesh products represent “the next medical device controversy”? That was the suggestion of an article over on Business Week. The devices, which have recently been implicated in roughly 600 lawsuits, have been getting a lot of attention lately (along with metal-on-metal implants). In July, FDA warned that there had been a fivefold increase in the number of women suffering complications caused by the devices. The number of lawsuits began to build after FDA made that announcement. “We’re getting an amazing number of calls,” explained attorney Bryan F. Aylstock of Aylstock, Witkin, Kreis & Overholtz (Pensacola, FL) in the Business Week piece.

A good analysis of the issue can be found on twitter, of all places. Chris Thierfelder a self-described med-tech innovator based in Santa Barbara, CA explains, in a series of messages, his views on FDA's proposal to reclassify transvaginal mesh products as Class III devices—a move the agency says would better reflect their risk to patients. Thierfelder, however, thinks the move would be severe. Class III devices are usually used for life-or-death scenarios, he points out. Examples of such devices include heart valves and pacemakers. (Note: While there is a correlation between risk and classification, the device classification scheme used by FDA has more to do with the complexity of the device than risk per se.)

Vaginal mesh currently fall under the Class II designation. Reclassifying them would bar the products from eligibility for the 510(k) approval process. In addition, achieving Class III approval requires controlled, clinical data to be gathered before the product is available for open market use. That can takes years to acquire.

Thierfelder looks at the base numbers: For vaginal mesh, there were roughly 1500 failures per 75,000 devices over three years. The majority of incidents could be corrected while the patient was under sedation.

An article on CommonHealth explains that many pelvic surgeons don’t agree with FDA’s proposal to reclassify the vaginal mesh as a Class III device. “We have some significant disagreement with the conclusions reached [by FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” states a letter that was signed by more than 600 pelvic surgeons.

Mesh has the advantage of being inexpensive and generally effective. Thierfelder calls it “a [relatively] low-risk, low-cost solution to a quality-of-life problem. On the other hand, Class 3 devices are usually used for life-or-death situations.  “Classifying mesh as class 3 would wipe out a very effective method for treating a big problem. What fills the void?” he writes. He compares the use of the mesh with traditional surgery, which has a "debatably higher rate of more severe complications."

In the end, Thierfelder sums up his position like this: “In the end, re-classification of devices is very hazardous, and should be taken in the broader context...Not that business is greater than safety, but be mindful," he concludes.

That's a convincing argument. And one of the most thorough ones on the issue I've seen, well, anywhere. In case you use twitter, I recommend following Thierfelder at @Hamlet.

—Brian Buntz

Update:

Thierfelder has left a comment to this post (see below), explaining there were some other points that weren't mentioned above.

In essence, he explains that consumers who have suffered complications from the devices have the right to be upset. He adds that some earlier versions of the devices were "not so good"; current versions are much safer. In addition, physicians would have likely benefitted from more in-service training, which may have led to a decrease in complications. More data on the safety of the devices also would have been helpful: "[O]nly in the last couple of years have we started figuring out who's a good candidate. There's new data, no thanks to industry," he adds. 

In the end, he says that industry can self-correct but that is is unlikely for it do so quickly enough.

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