Thank you for being so generous, Mr. Chair.
Thank you too, Mr. Batters.
You said that you took into consideration the 65,000 pages provided by the industry, by Inamed Corporation and Mentor Medical Systems, before approving silicone gel-filled breast implants, also known as gummy bear implants. However, you also said that you consulted another expert to determine that magnetic resonance imaging was not necessary after two years.
Do you mean to say that the information contained in the 65,000 pages provided by Mentor Medical Systems and Inamed Corporation is unfounded? What I have here comes from those documents. In their own words, they say:
Therefore, you should advise your patient that she will need to have regular MRIs over her lifetime to screen for silent rupture, even if she is having no problems. The first MRI should be performed at three years post-operatively, then every two years thereafter.
We know that young women who have had MRIs within the past two years are not supposed to have access to silicone gel-filled implants for breast augmentation.
Will they still have access through the special access program for medical devices?