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PANEL MAKES RECOMMENDATIONS ON BREAST IMPLANTS

 PANEL MAKES RECOMMENDATIONS ON BREAST IMPLANTS
 ROCKVILLE, Md., Nov. 14 /PRNewswire/ -- FDA's General and Plastic


Surgery Devices Panel has recommended that the agency allow silicone breast implants to remain on the market while the manufacturers compile additional data on their safety and effectiveness. A statement by Elizabeth Connell, M.D., chairperson of the panel follows:
 CHAIR PERSON'S STATEMENT
 Breast Implant Panel Meeting
 To begin with, I'd like to express my gratitude to the members of the advisory panel, some of whom rearranged their schedules at the last minute in order to be with us for the last three days. This was a longer-than-normal panel session, and we worked each day until well into the night. I think the panelists are returning home to a well-deserved rest.
 In advising the FDA about breast implants, this panel of experts had two basic tasks. The first was to evaluate whether the scientific information presented to FDA by the four implant manufacturers was sufficient to show a reasonable assurance of the safety and effectiveness of these devices. The panel carefully examined the data in the applications and found that they were not sufficient to establish with reasonable certainty that these devices are safe and effective. I should emphasize that this does not mean that we found evidence that the implants are unsafe. Instead, we found that there was not enough information to be certain about risks and benefits, one way or the other.
 For example, the data did not make it clear what proportion of women experience the more common side effects of these implants, such as rupture or contracture, nor did they satisfactorily address the issue of whether the implants can interfere with mammography examinations to the point of compromising our ability to detect early breast cancer. The data also did not resolve the issue of long-term risks -- for example, whether the implants can increase the risk of autoimmune disorders or cancer.
 Having concluded that none of the applications from the four firms had enough information, our next task was to advise the FDA about whether continued availability of these devices would be necessary for public health. If the FDA decides that this is the case, then it may be possible to have them remain on the market, at least in some limited form, while the companies collect more data.
 The panel voted unanimously that there is a public health need for these implants and thus that they should continue to be available while FDA requires the manufacturers to collect additional data to fill the gaps in knowledge about safety and effectiveness. Many of the panelists commented that the needs of augmentation and reconstruction patients should not be separated. Several panel members expressed the need for a breast implant registry, and others pointed out the importance of adequate informed consent for women. A strong theme throughout the discussion was the need for FDA to hold the companies strictly accountable for providing the necessary data without delay.
 -0- 11/14/91
 /CONTACT: Susan Cruzan of the FDA, 301-443-3285/ CO: Food and Drug Administration ST: Maryland IN: HEA SU: PS -- NY115 -- 1317 11/14/91 19:26 EST
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Date:Nov 14, 1991
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