The FDA and breast implants

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The FDA expert panel has voted against approving Inamed's silicone breast implants:
"This hearing was premature," said panel member Amy Newburger, a suburban New York dermatologist, after the vote. "I don't see how we can get or give adequate informed consent for our patients based on the data we've seen."

Inamed Corp. sought the new advisory meeting a year after the agency rejected its earlier application and presented one additional year of safety data. While the panel members complimented the company on its research, they concluded there wasn't enough new information on key issues, including why some implants leak, the effect of released silicone, and the long-term risks of intact implants.

Here's the thing, though: these exact same breast implants are already available. It's just that you can only get them for reconstructive surgery after you've had a mastectomy. So, the question at hand is whether they'll be allowed for breast enlargement. There's no medical need for you to have normal-sized breasts after a mastectomy, it's basically a cosmetic issue--in the sense of being about how your breasts look and feel. Effectively, the FDA is now in the business of saying "These people have an appearance that's sufficently problematic that they're allowed to have implants but these other people do not."

It seems to me that there's something fairly problematic about the FDA making this kind of decision. It's certainly not the same as the usual kinds of decisions that FDA makes, namely is something safe (i.e., does it have a risk level below a given amount) and is it effective (i.e., does it work). These are in some sense empirical issues, though of course it requires some real judgement to interpret the studies, especially because the acceptable level of risk depends on the seriousness of a condition (HIV treatments can obviously be a lot more dangerous than treatments for minor acne.)

In this case, however, it's basically a matter of saying that "reconstruction" is OK but "enhancement" isn't. Given that neither is medically necessary, why is this a decision that the FDA should be making in the first place?

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10 Comments

I don't believe reconstructive surgery allows silicone implants, and in fact a number of lobbyists at the panel were womens groups that wanted silicone implants for their reconstructive surgery but could not have them.

Taken from the FDA's web site on breast implants:

"Breast implants are designed for treatment of augmentation, reconstruction, and revision patients. While many women believe breast implants cause illnesses, such as autoimmune disease, this is not proven at this time. However, most women with breast implants will experience local complications, such as pain, capsular contracture, and rupture/deflation. You may need to have nonsurgical treatments or reoperations to treat local complications. Breast implants do NOT last a lifetime. You should be prepared for long-term follow-up, reoperations to treat complications, and personal financial costs." -- http://www.fda.gov/cdrh/breastimplants/handbook2004/introduction.html


Your argument ignores the discussion of whether each of the different classes of patient treatment experience different types of complications. Many (if not all) FDA approvals are conditional for complications.

Is there some reason to believe that patients who have had mastectomies will have different sets of complications?

I posted the remark because it is normal for the FDA to conditionally approve medical treatments for certain patient treatment classes based on the samples in studies and observed complications. So the first place I would look for an explanation to your outrage is the available data and the commentary about it.

The information available from the web site says that the studied sample sizes for each of the treatment groups varied and the nature and severity of their complications varied. This is inline with the explanation provided to the media, which says that, although the FDA advisory committee was impressed with the company's work, it was insufficient to justify approval.

I don't find this argument very convincing. Drug and medicine approval studies almost ALWAYS involve population subgroups and yet stuff very frequently gets unconditional approval. Unless there is some reason--other than just a lack of data--to think that the subgroups would behave differently, I don't see any support for the argument you're making.

Very rarely does a treatment get unconditional approval for all potential classes of treatment groups. The web site has their official stats, which specify less than 1% of applications.

I'm curious how you would explain the FDA advisory committee member statements which specified that this was the reason they voted for failure to approve. I would cite them for you, but it seems like you prefer outrage to figuring out how they justified their actions.

At this point it's worth going back to the data.

It turns out that there actually *is* a difference between indications but it doesn't really support your argument. At least in the case of Inamed, the data we have suggests that the risk of rupture is far greater in cases of breast reconstruction than in cases of breast augmentation. (see page 53 of the FDA's presentation.) How, exactly does this constitute an argument for approval for reconstruction and not augmentation?

IMHO, the most effective way to argue with FDA decisions is to question their assumptions. In your critique, you question the original policy decision that "reconstruction" or "augmentation" are medically necessary. But whether "reconstruction" or "augmentation" are medically necessary isn't part of the question under review.

Somehow, the FDA got to the point where it became public policy that "augmentation" and "reconstruction" are legitimate treatment classes. Hidden inside the policy history will be much more information about what the FDA views as high reward or high risk for these types of patients. And this information will be driving their cost/benefit decision by treatment class.

In your original post, you were surprised that one treatment class would be allowed while another wouldn't. One of the reasons that the data is collected by treatment class is to allow the FDA to approve treatment for a specific class. And it happens frequently. The specifics of risk and reward are examined for each treatment class as part of the application.

I'm happy you went back to the data to examine risk of rupture for two treatment classes. But now you need to put yourself in the shoes of the advisory committee members to discuss risk versus reward for each of the classes. And since your analysis of the data isn't bounded by the framework they've set up to evalute the risk/reward decision, I wouldn't expect you to necessarily make the same decision.

In summary, if you want to make the argument that the two treatment classes aren't distinct, then I might be swayed if you did it with more precision. If you want to make the argument that the decision framework they used is flawed, then tell us which aspect of the framework is flawed. But, so far, most of your discussion sounds like someone yelling in outrage.

"Hidden inside the policy history will be much more information about what the FDA views as high reward or high risk for these types of patients."

Yes, this is exactly what I'm complaining about. Since the risk for reconstruction *exceeds* the risk for augmentation, the decision is clearly based on an assessment that the benefit for reconstruction exceeds the benefit for augmentation. Since both are essentially cosmetic procedures, the FDA is basically making a judgement about what the preferences of the patients *should* be (we don't need the FDA to decide what their preferences *are*, the market can do that). I don't consider that a legitimate topic for regulation. Am I outraged that other people seem to think it is? You bet.

The evidence you pointed to doesn't lead to your conclusion. One example would be that patients with rigourous routine follow-ups in their treatment plan may more safely consume certain treatments than other patients, even when the risk appears lower to the other group. The patient risk summary charts in an overview won't contain this type of information. And only someone familiar with the policy history and medical science will be able to articulate crisp failures in the FDA Advisory committee findings.

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