When the USFDA lifted a nearly 2 decade moratorium on the use of silicone gel breast implants for cosmetic surgery indications in 2006, there were two puzzling things added to the product labeling.

1. The use of silicone gel implants should be limited to women >22 years olds.
2. That women should undergo routine MRI screening of their implants for rupture every 2-3 years.

The first instruction re. an age restriction on women 18-22 is patently absurd and is a nod to the "unique" political history of silicone breast implants in the USA. One more thing we thank lawyers for!


The second suggestion re. MRI was always puzzling, particularly as the rupture rate is so low for modern implants through the first decade where the FDA would otherwise be having patients undergo 5 screening MRI's (at year 3,5,7, & 9). This intuitively is throwing money down the drain as the yield is low and violates what most people consider appropriate in a screening test.

New data and review of the literature from the University of Michagan suggest that while MRI is fairly accurate in detecting implant-related problems, it is 14 times more likely to detect them in women with implant-related symptoms than in women without symptoms.It has been concluded that because most women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women is probably much,much lower and calls into question the whole idea about routine screening for rupture. Beyond the issue of accuracy, the authors comment that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown. To date, there is no single systemic disease or illness clearly attributable silicone gel implants despite them being the most studied medical device in the history of medicine.

Hopefully this will lead to the updating of the current FDA labeling for these devices that causes some confusion for patients and adds significant extra expense for no benefit.

Rob

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One of the peculiarities of the USFDA process during silicone implant reintroduction in 2006 was the labeling on the devices recommending routine MRI surveillance of implants for rupture. When you step back and look at the proceedings and "unique" American history with breast implants, you can see that this was more a political concession to the anti-implant activist lobby then evidence-based medicine.

The FDA labeling currently suggests MRI's at 3 years post op and then every 2 years subsequently. It will be interesting with the coming form stable "gummy bear" implants whether or not this recomendation is still maintained.



Why 3 years for the first MRI?

That was the first data point with any ruptures reported in the FDA data during clinical trials. While there will be a certain failure rate associated with any manufactured device, it's likely that early failures of silicone devices were from missed trauma to the implant during insertion. Education courses on proper techniques for implant handling and insertion in recent years have emphasized ways to minimize this risk by suggesting larger incisions for gentler introduction and better visualization during closure.


But does it make sense to do this?

Clearly it does not. On this point, there's pretty much international agreement (USFDA excepted).

We've actually got a pretty good handle on rupture rates of 4th generation implants (conventional devices used for the last 15 years or so) up thru a decade, where it's pegged around 6-8% at 10 years based in two pretty solid studies on single devices by the two major implant makers Mentor & Allergan. If you take that and work backwards from the FDA recommendation, you're doing up to 4 MRI's during the first decade where the rupture rate is either almost nonexistent (years 3-7) or in the low single digits (year 9).



Whether you're screening an asymptomatic population for ruptured implants, colon cancer, breast cancer, or aortic aneurysms there's trade offs between costs and risk reduction. For tests to be effective for screening, they must satisfy both criteria. For a number of cancers, screening tests often fail this goal.

Take screening mammograms or breast self-exams for instance to detect breast cancer. In non-selected groups of women, both cancer detection modalities increase both cost and morbidity from unnecessary procedures without materially affecting death rates from breast cancer (arguably the whole point of screening). It's been persuasively argued when reviewing the data, that screening mammograms can be deferred to age 50 for low risk women (as opposed to the current recommendation for age 40) and perhaps discontinued altogether for women in their 70's with no affect whatsoever on breast cancer death rates. BTW, this same pattern of "dodgy logic" of routine screening also exists in regards to male prostate cancer and lung cancer screening in smokers.

Anyway, back to implants......

At the end of the day it's just hard to support screening implants for rupture in asymptomatic patients on either a cost basis or benefit basis. As it's been established that ruptured silicone implants (silent or otherwise) do not appear to correlate with systemic illness, the clear benefit of screening asymptomatic women is hard to establish. A team of doctor's from the world famous Sloan-Kettering Memorial Cancer Center agreed with this sentiment in a recent paper, Silicone Breast Implants and Magnetic Resonance Imaging Screening for Rupture: Do U.S. Food and Drug Administration Recommendations Reflect an Evidence-Based Practice Approach to Patient Care?


Rob

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Last week I talked about the recent literature re. the new recommendations by the American Cancer Society on breast MRI's for cancer screening. I touched on both the financial considerations as well as the potential for increased screening to cause more problems then it solved.

There's an excellent overview of this in the Washington Post which crystallizes many of these concepts more eloquently then I. Click here to read.

From the article:

...if you really want to find as much cancer as possible, we would suggest whole-body CT, MRI and PET scans every month. But that would be absurd. Why? Because the goal is not to find more cancer. The goal is to save lives. The two goals are not the same...Over-diagnosis is the reason that the number of people with cancer diagnoses is increasing much more quickly than the numbers dying from those cancers.

For breast cancer, MRI may (or may not) be the best test. We just don't know. The only way to know is to do a true experiment -- a randomized trial -- in which half the participants have MRI while half have mammograms, and determine how many die from breast cancer in each group. These experiments are a lot of work and they take a lot of time. But they are the only way out of what is beginning to appear to be a vicious cycle: more and more testing finding more and more cancer, with the assumption of benefit...Early detection is a strategy that turns many more people into patients. Its effect on how many people die is relatively small, at best. People will die from cancer, whether or not they are tested.

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There's another paper today challenging conventional wisdom on how effective screening studies are in the prevention of breast disease. In this instance it's computer-aided detection (CAD) mammograms, which were billed as a way to increase the effectiveness of interpreting mammograms. It uses advanced image recognition software to screen for abnormalities. Despite little data, this technolopgy was quickly adopted. Many mammography centers adopted this technology and were incentivized by medicare with additional payments ( ~ $20 per study) to use CAD. Note: When you do thousands of mamograms a year, this $20 per study can be serious money in someone's budget

CAD is apparently more sensitive then humans to abnormalities, but less able to distinguish malignant from benign. It also tends to identify a number of ductal carcinmona in situ (DCIS) lesions, which if left undiscovered may never turn into invasive breast cancer (aka. "real" breast cancer). Much like small prostate cancers in males, where many would die with it rather then from it, we as yet have no predictable way of tell patients that nothing will come of it and are forced to offer more aggressive surgical and medical treatments and their associated morbidity.




This report is the mirror image of the other large counter-intuitive finding we saw recently with screening CT scans for lung cancer. (ie. we find more disease but don't improve outcomes about death from cancer, while actually increasing morbidity and anxiety for patients.

While I'm off on this I'd like to dovetail on imaging studies for breast implants. With the 2006 FDA approval for silicone gel breast implants came a recommendation for routine screening by MRI of all implant patients starting 3 years post-op then every 2 years. This illogical and unenforceable (and unfunded) suggestion is surely going to widely ignored by patients and I'm not sure I'd blame them. For the period which would encompass the first 2 MRI's (five years out) the rupture rate of an implant in augmentation patients of "regular" silicone implants is likely under 1-2% while after 4 MRI's (10 years out)it's likely only 6 or 8%.

What drove this recommendation by the FDA? Most point to the highly charged political environment that still exists in America over this. One month prior to the FDA approval, Canada released the last of it's token restrictions on the devices and commented that while MRI screening was discussed, routine use was not evidence-based medicine. What do other countries do? They image implants selectively and usually start with ultrasound and reserve MRI for equivocal findings. As consequences of rupture tend to be confined to the breast and we know many woman may go years or decades with asymptomatic rupture, this is the position that makes the most sense to me. If you were to start MRI screen in asymptomatic women it would make sense to do this at 10-12 years when you sit and crunch the numbers.


The form-stable cohesive gel implants from Inamed
(picture below), Mentor, & other companies will make this topic be revisited when they are likely (you never know with the politics of the FDA)approved for general use later this year. When you have a device like Inamed's 410 implant with rupture rates so low as there are no data points to even do projections on rupture rates will the unsound MRI recommendation be attached to it as well? Keep in mind there has also been an issue of a number of false positive MRI's read out with the Inamed 410 and some of the dual-lumen devices (part saline-part silicone)in some of their clinical trials as they look somewhat different on MRI

Stay tuned!

Rob Oliver Jr. MD
www.oliverplasticsurgery.com

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The American Cancer Society (ACS)came out with a fairly bold recommendation yesterday for dramatically expanding the use of MRI for screening breast cancer patients. A summary of this by WebMD can be read here.

The proposed groups which fall under these new guidelines are:

1. They carry mutations in the BRCA1 or BRCA2 breast cancer genes.

2. They have a parent, sibling, or child with a BRCA1 or BRCA2 mutation, even if they have yet to be tested themselves.

3. Their lifetime risk of breast cancer has been scored at 20%-25% or greater, based on one of several accepted risk-assessment tools that look at family history and other factors.

4. They had radiation to the chest between the ages of 10 and 30.

5. They have a rare medical condition linked to breast cancer -- Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley-Ruvalcaba syndrome -- or have a parent, sibling, or child with one of these syndromes.

When you calculate the groups who fall into the nominally "high risk" group, it's somewhere between 1.6 to 2 million women annually who would be suggested to have MRI's. Right now it costs somewhere between $800-2000 per study so this is well over a billion dollars of potential new imaging study costs for our health care system (which is not pocket change for even federal programs like Medicare).

This will be interesting on how this plays out. The growth in imaging studies (mostly CT/MRI)are already one of the budget busters when you consider health care on a systems basis. Do not expect health insurers to quickly accept this recommendation by the ACS until they are forced kicking & screaming with long-term outcome data. Counter intuitively, we learned (read here)not to long ago that aggressively screening patients presumed to be at risk for lung cancer had ZERO effect on cancer-specific mortality and caused a great deal of morbidity from the work up of masses that may never have caused a problem.

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