Is everybody out of step but me?

Unfortunately, it's off limits to you common rabble, but I'm going to discuss this medical news essay by Bridget Kuehn in the new JAMA anyway. (This is the sort of thing NEJM makes open access -- but so far JAMA has not succumbed to the awesome power of Stayin' Alive.)

As you may recall from previous episodes, the FDA sometimes requires medical device makers to conduct post-marketing safety studies of medical devices as a condition of approval. The only problem is, this "requirement" is not, in fact, a requirement. The companies often don't do it, or they sort of kind of start the studies but never complete them, and the FDA doesn't do anything about it. As Kuehn puts it, "Critics argue that tougher sanctions from the agency or greater collaboration from government agencies to ensure collection of the necessary data may help resolve this problem."

My only comment on that is, "Well, duhhh."

However, what I'd really like to discuss here is the specific issue of silicone breast implants. The drama around this was pretty well publicized a few years back. Concerns about silicone leaking into the body and causing disease led to a 14 year ban on plastic boobs but the FDA approved two products in 2006, with the condition that the companies conduct post marketing safety studies. They were required to follow at least 40,000 women for 10 years, but after 3 years, the follow-up rates are only 60.2% for one company and 21.8% for the other. At this rate, the FDA concludes, they won't have enough statistical power to detect uncommon, but possibly very serious, outcomes.

Okay, that's bad, but here's what we already know:

1. There are frequent "local" complications such as implants rupturing or contracting into a hard mass, wrinkling, scarring, pain, asymmetry and infection. Remember that the only point of these implants is cosmetic.
2. 20-40% of women who got boob jobs for cosmetic purposes had them removed within 10 years; 40-70% of breast reconstruction patients had them removed.
3. There appears to be a small increase in the risk of anaplastic large cell lymphoma. It's rare, but if it does happen, you'll be lucky to live 5 years.

Ladies, listen up. Some guys like big bazongas, it's true. But believe it or not, some guys, probably just as many, don't, even if they aren't supposed to admit it. I don't know, given the above facts -- plus what we don't know due to the companies figuring that what you don't know can't hurt them -- whether these really ought to be approved for sale. Personal choice and all that. But knowing what you know now, is this something you really want to do? Just to appeal to a sub-set of men who happen to have a specific fetish and don't love you for your beautiful mind after all? Just askin'.