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| FDA Approves Saline Breast Implants |
| By Pat Burke |
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The saline-filled breast implants made by two U.S. manufacturers, McGhan Medical Corp. and Mentor Corp., may remain on the market the Food & Drug Administration ruled May 10, 2000 and information on the risks should be made available to women so they can make informed decisions.
The saline breast implants, which are made of a silicone shell filled with sterile salt water, were approved for breast augmentation in women 18 years or older and breast reconstruction.
The ruling was the first formal approval of the devices which have been on the market for over 30 years, well before the FDA was given the authority to regulate medical devices. Recently, the FDA ordered manufacturers to prove that their devices were safe. The companies were to look at short-term complications associated with the products such as infection, capsular contracture, leaking/deflation and implant removal. As a result, about 9,000 women were enrolled in three McGhan studies and two Mentor studies.
"Although there is benefit to some women from having breast implants available, there is now a much clearer understanding of the risks involved," said FDA Commissioner Jane E. Henney, M.D. "With the data that has been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks."
An FDA booklet which describes the risks of breast implant surgery is to be made available by plastic surgeons to give to potential patients before the day of surgery. It is also available online at:
http://www.fda.gov/cdrh/breastimplants/
The FDA decision does not affect silicone gel-filled breast implants which currently can not be marketed and are available only to women participating in FDA-approved clinical studies.
As a result of the FDA ruling, three smaller competitors, all U.S. branches of foreign companies, must stop selling their implants in the United States as of Monday, May 15.
To read the complete FDA, U.S. Department of Health and Human Services media release go to:
http://www.fda.gov/bbs/topics/NEWS/NEW00727.html
Getting Started
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