Abstract
A panel of advisers to the US Food and Drug Administration last week unexpectedly recommended approving silicone breast implants made by Mentor Corporation, just one day after rejecting a similar product from a competing firm.
In a seven-two vote last Wednesday, the panel recommended approving silicone breast implants but attached nine conditions. The conditions included more rigorous monitoring of safety issues, including the effects on pregnant women; mandatory education for doctors and patients; and setting up a national register of recipients. On Tuesday, however, the panel had voted five-four against approving silicone implants made by a competitor, Inamed Corporation, because of a lack of convincing evidence of safety.
In a seven-two vote last Wednesday, the panel recommended approving silicone breast implants but attached nine conditions. The conditions included more rigorous monitoring of safety issues, including the effects on pregnant women; mandatory education for doctors and patients; and setting up a national register of recipients. On Tuesday, however, the panel had voted five-four against approving silicone implants made by a competitor, Inamed Corporation, because of a lack of convincing evidence of safety.
| Original language | English |
|---|---|
| Pages (from-to) | 919-919 |
| Number of pages | 1 |
| Journal | BMJ (Clinical research ed.) |
| Volume | 330 |
| Issue number | 7497 |
| DOIs | |
| Publication status | Published - 23 Apr 2005 |