November 17, the US Food and Drug Administration (FDA) approved—after a 14-year hiatus—the use of silicone-gel–filled breast implants for reconstruction in all women and for augmentation in all but the youngest patients. By now, this is certainly not news to you, but it does merit some discussion.
The approval did not come without a price—in this case, extensive follow-up studies on the safety and efficacy of the implants. Surgeons, with their patients’ cooperation, are required to gather information on local complications; connective-tissue and neurological disease; effects on reproduction, lactation, and patients’ children; cancer; suicide; potential interference with mammography and magnetic resonance imaging (MRI); and, of course, rupture rates. In addition, there are requirements for manufacturers to conduct postapproval studies that include patient focus groups and laboratory characterization of device failures.
The manufacturers’ responsibilities are considerable, but in reality they are not much more onerous than those typical for medical devices in general. But the responsibilities placed upon physicians and patients are quite extraordinary. In a society in which people are busier and more mobile than ever, surgeons will have to make sure that their patients come in for MRI screenings (to detect potential ruptures) every 2 years over their lifetimes—or at least as long as the implants are in place.
As the FDA pointed out in the news release that announced the approval, the cost of all this screening might be more than that of the procedure itself, and it may not be covered by medical insurance. On top of this, managing the screening may be almost impossible for the surgeon. Once the procedure has been performed and the patient has gone on with her life, what leverage does the surgeon have to ensure that she will return on a regular basis for the screenings? Obviously, many if not most women will be sufficiently concerned about their health (and that of their unborn children) to come in for their MRIs, but we all know that as time goes by, life has a way of replacing past concerns with present ones.
If an implant ruptures and the rupture is not detected because the patient hasn’t had her regular MRI, where does the responsibility lie for any subsequent health problems? You could say, “Well, it’s the patient’s fault—she didn’t have her MRI,” but there is always the chance that an aggressive attorney will convince a court that the surgeon and the manufacturer bear liability as well. Surgeons would be well-advised to scrutinize potential silicone-implant patients carefully and reject those who would not be as vigilant as they are.
This long-term potential liability may be one reason that, in a recent survey of PSP readers, nearly 40% said that they would not use silicone-gel–filled breast implants, and another 17% said they would use them only sparingly. The survey was taken within 2 weeks of the implant approval, and people might certainly change their minds one way or another as time goes by. PSP will of course keep a sharp eye on trends in breast implants and provide information on the latest developments.
Interestingly, alternatives to breast implants (silicone or saline) have begun to surface—or resurface, as in the case of fat transfer to the breasts. This technique, which was officially banned by the American Society for Aesthetic Plastic Surgery (ASAPS) in the 1980s because of poor fat survival and high complication rates, began to make a comeback in the late 1990s, and promising results were reported in last April’s ASAPS scientific meeting. As one paper stated, fat will not replace augmentation with implants, but it will provide an attractive alternative for some patients. Look for much more on fat transfer to the breasts in PSP in 2007.
The road to safe and effective breast augmentation has been a long and winding one, and we have come to the end by no means. How will the resurgence of silicone-gel implants affect your practice?
