Bloomberg ran an interesting article yesterday that raises the issue of whether there should be a vaginal mesh recall. There is a lot of data coming out now that supports the idea of a recall. At some point, these pharmaceutical companies need to cut their losses and not only stop making these vaginal mesh products but also recall the ones that are already on the market.
New information continues to underscore what is becoming increasingly obvious: these surgical implants are unsafe. The FDA is starting to get wind of this fact, and last month expressed more concerns about the risks of transvaginal surgical mesh used to treat pelvic organ prolapse.
This article also talks about the issue moving forward: how these defective mesh implants came on the market in the first place. As it should, it takes a long time to get approval to put new drugs and medical devices on the market. But the FDA has a loophole called the 510(k). This process is a backdoor through the approval process companies usually have to go through to get a medical device on the market. It allowed vaginal mesh manufacturers a free pass on proving their product was safe and effective since it is “substantially equivalent” to others already for sale. One problem with this loophole: the definition of “substantially equivalent” is ever-expanding. The FDA is finally catching on to this. Later this week, the FDA will gather more opinions from doctors and researchers as to whether we need to rewrite 510(k) to make it harder to get untested products on the market.
Do I think they will recall these vaginal mesh products? I really don’t. Sadly, I think the big reason is that companies like Johnson & Johnson, just one of the vaginal mesh implant manufacturers, have learned that recalls attract attention from plaintiffs’ lawyers that, at least arguably, leads to more lawsuits if for no other reason than it draws attention to the problem. Instead, I expect vaginal mesh implants to die a slow death. Doctors will stop using them – they already are – and these companies will do the soft recall of just not selling the products anymore.
One more point worth making: one of the doctors in the Bloomberg article said this in opposing a vaginal mesh recall:
We do these surgeries all the time without risk. Thousands and thousands of these surgeries are done without complications. The data is still emerging. It’s easy to react but what needs to be done are good studies.”
Without risk? Seriously? I have to think this is a misquote. How can anyone say after all that has happened with these implants that they are being put in with no risk? It is inconceivable to me that someone could suggest there is no risk. It is a surgical procedure.