Monday, April 11, 2005

Silicone Breast Implants and the FDA

FDA hearings are beginning today on the subject of silicone breast implants. This has been an incredibly contentious controversy ever since the lawyers got involved in this issue in the 1990's. Currently, silicone can only be used in the setting of an ongoing research protocol.

It is noteworthy that this is one of the very few cases where the FDA set aside the recommendations of an independent advisory committee and refused to allow such implants to be generally marketed. One has to think that this was because of the tremendous amount of press coverage of a very vocal minority of patients and lawyers who succeeded in creating the perception of a risk when no real risk has ever been clinically demonstrated.

Emotions will be high because strong women's advocacy groups on both sides of the issue will be pitted against each other. On the one hand, women who claim to have been injured by the implants will present personal, but anecdotal stories about their own poor experiences. They will face women who rightly demand access to a product that leads to significantly improved cosmetic results. This especially in light of the limited data available pointing to actual risk.

If you're interested in a good review of the world literature regarding silicone implants and rheumatologic disorders, two good references are here and here. You'll need a subscription to Arthritis & Rheumatism and the New England Journal of Medicine to access the complete articles.

A very complete, but technical, review compiled for the European Parliment is here. This last citation not only reviews the scientific literature but also reviews the results of questionaires sent to special interest groups such as women's self-help groups, surgeons and implant manufacturers. This review also addresses numerous other issues such as the impact of silicone implants on mammography and breast cancer screening, risk to breast-feeding infants, local complications and even psychological morbidity.

What is known about silicone breast implants?
  • There is no data to support an association of silicone breast implants with any specific rheumatological disease (this includes women with MRI-documented implant rupture).

  • There is no data to support an association with any known neurological disorders.

  • One study demonstrated an association of silicone breast implant and respiratory cancers but such differences disappeared when tobacco use was controlled. Apparently patients opting for breast implants smoke more. Another study showed similar findings but did not have the ability to control for smoking.

  • There was one study that showed an a barely statistically significant association with implant rupture and fibromyalgia (a poorly charactorized disorder of unknown etiology). There were some significant methodological problems in this study, most notably that the diagnosis of fibromyalgia was self-reported.

  • A slight increase in congenital malformations were noted in pregnant women with implants. Further analysis, however, showed no such association when malformations among children born prior to implant surgery were compared with malformations in their siblings born after surgery.

  • There was great variability from study to study but the risk of local complications (deflation, scarring, poor cosmetic result, pain, etc.) of silicone breast implants is real. Unfortunately, no good comparisons of the silicone versus saline-filled implants have been done.

  • The quality of mammography is impeded with implants but no studies are currently available on late diagnosis of breast cancer or mortality differences.
Given the politically-charged nature of this debate, it will be very interesting to see what the FDA's final decision will be.



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