In a not unexpected conclusion, yesterday the United States Food & Drug Administration re-affirmed their 2006 decision to reintroduce silicone gel breast implants into the United States market for cosmetic indications. In statements from the FDA, they explained that no new information has arisen to question the safety or efficacy of the devices for intended use. As has been discussed on Plastic Surgery 101 a number of times, this is not really news and has been accepted world-wide for a number of years now. Hopefully this statement from FDA heralds the availability of the new form stable "gummy bear" silicone implants here in the United States which have been available everywhere else for almost 15+ years.
Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons (ASPS), more than 70,000 others received implants for breast reconstruction.

The most disappointing finding was that only ~60% percent of women enrolled in a 1,000-patient study of one manufacturers implants are still accounted for after eight years. A larger study of 40,000 women conducted has lost nearly 80 percent of its patients after just three years. Diana Zuckerman of the National Research Center for Women and Families, one of the most prominent (and persistent) anti-implant activists, cried foul and suggested that most medical journals would not publish the studies cited by the FDA because of the missing data. I'd agree with her, but for different reasons. She's implying safety issues exist (which they don't by and large), while I'm more interested in outcome data to understand how to reduce re-operations.

Why the relatively poor follow up in the FDA trials?

Dr. Phillip Haeck, president of the American Society of Plastic Surgeons (ASPS)sums it up saying that, "When women are happy with their implants they tend to feel that a regular follow-up is pointless - it becomes a nuisance and an unnecessary expense". I'd agree 100% with that.

It also begs the question of what exactly are we trying to demonstrate with the FDA follow up studies. There is overwhelming world-wide information that suggests safety at this point. It would be nice to have a little more data on longevity so as to better counsel patients on when to consider routine exchange with prior devices, but as we're on the cusp of a major design change in the polymers that make the implant almost impossible to rupture (the "gummy bear" form stable devices) we're going to quickly lose interest in exhaustively studying older devices. This kind of technology advance has always created problems about making conclusions with medical devices, as you end up comparing apples to implants :) (bad pun alert).

Rob

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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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This past week the FDA had some hearings to discuss the issues of dermal fillers (like the popular Juvederm, Restylane, Sculptura, & Radiess) and BOTOX. The use of such products has exploded in recent years and we've seen some real complications reported. The majority of such problems are usually minor and transient as most of these products degrade or wear off. However, there are some products whose effects are permanent (like some of the micro-silicone injectables which aren't used in the US) or last up to several years (like Radiess or Sculptura).

The FDA presented data on over 800 patients who suffered reactions after injection with dermal fillers between 2003-2008. There have been no deaths reported to the FDA, but almost 80% of the patients required follow-up treatment of some sort. Most of these were minor swelling and redness (which isn't really a complication, but expected IMO). However, the FDA also received reports of "serious and unexpected" problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

Most troublesome complications of these fillers are those injected around the eye to fill the hollow "tear trough" that develops under the lower lid with aging. Injections in that area offer a solution that cannot be reliably fixed surgically as the changes are produced from a combination of atrophy of the cheek bone (malar complex), deflation of the fatty tissue of the orbit/cheek, and thinning of the skin rather then something descending and producing loose skin. The thin skin of the lower lid is unforgiving for imprecise injection of dermal fillers as it shows each and every irregularity. In addition, inadvertent injection into a blood vessel in this area has been associated with embolic phenomena to the eye which can produce blindness. Natasha Singer, the NY Times go to girl for cosmetic surgery articles wrote a nice summary up last week (see here).

Not directly addressed at this hearing was the hornet's nest of exactly who is actually doing these procedures, particularly those indications that are still "off label" for the injectable. (Natasha, if you're reading this BTW that subject is screaming for an feature by you....Rob) To this point, states have been reluctant to engage the issues about qualifications and credentialing for doctors performing aesthetic medicine or surgeries. It strains common sense to allow people who are un or undertrained to perform these types of procedures. IMO, if you're not trained in lower eyelid surgery (a la an opthomologist, plastic surgeon, or ENT surgeon) you don't have much business pushing injectables or fat grafting that area - it's that finicky! In many other states, physicians are not even required to do these procedures themselves but are free to delegate them to low level providers or nurses.

Rob

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Wow! I didn't see this coming so soon. The FDA unexpectedly came in on the silicone breast implant approval. Sometimes it is amazing when science trumps politics as it did with this long overdue approval.

THERE ARE NOW NO COUNTRIES IN THE WORLD WITH ANY RESTRICTIONS ON THE USE OF SILICONE IMPLANTS

From the FDA press release:

“FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,” said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

"FDA’s decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the postapproval studies conducted by the companies.

“The silicone breast implant is one of the most extensively studied medical devices,” said Schultz. “We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once. This is valuable information for women who may be considering these products. ”

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