Monday, November 27, 2006

silicone breast implants- 2 steps forward and ? back

The FDA, in its infinite wisdom has ruled to allow all silicone breast implants for all patients. In the past 15 or so years the silicone implants have been limited to study patients who already had silicone implants or who had cancer surgery and elected to have them placed for reconstruction. The advantage of silicone is the improved texture for both appearance and feel compared with saline implants.
The entire controversy should have been avoided since there was never conclusive evidence that liquid silicone caused disease. However it was a bonanza for trial lawyers who made a lot of money and for a few patients who got away with the lie- albeit unwittingly. The controversy bankrupted the manufacturer, I believe Dow Corning, and caused great emotional consternation among doctors. And the know-it-alls in the medical community and the lay public had a field day celebrating their sky is falling mentality. The killer in the controversy was the revelation that Dow Corning knew the implants leaked and hid the information. The lie angered the juries and the retribution was the demolition of the company.
Now, to the best of my knowledge we have irrefutable proof that recipients of the silicone implants under very close monitoring have shown no evidence of disease. At the same time it is my understanding that all implants leak. So, knowing that the silicone is "safe" and knowing that it will leak into my body after implantation, and knowing that I could have saline implants which leak harmless salt-water, I wonder which I would choose were I to make such a decision for myself.
Once again, buyer beware!

2 Comments:

Anonymous Jeff Barson said...

Glad to see the blog Dr. Lack. Happy to have more docs blogging in this area.

12:36 AM  
Anonymous Robert H. Burke, MD,FACS said...

Dr. Lack. I appreciate and agree with most of your thoughtful comments regarding this issue. I have participated as an FDA approved researcher for the cohesive gel slilcone breast implant study. Participants had to fulfill strict guidelines, outlined by the FDA before they were admitted to the study. The clinical " rupture" or leakage rate for these implants is less than 1% over a ten year period. Also, the silicone is in the form of a cohesive gel which doesn't flow as opposed to the original silicone implants which were liquid, and therefore could folw to the surrounding areas if the outer covering of the implant was broken. This is a useful adjunct to breast augmentation, but will not replace saline filled implants. Many women complain of a feel of "rippling" of the saline implants, and can actually feel the outer covering of the implant when they move. Aosl, women who have had multiple deflations, those with chest wall deformities, and those requiring simultaneous mastepexy or uplift, may prefer these implants. Although they are FDA approved, they are limited to women who are over 22 years of age, and who agree to recommended followup which imcludes MRI at specific postimplant intervals.

10:10 PM  

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