Panel Backs Silicon Implants
Silicon breast implants taken off the US market 11 years ago should be made available to all women who want them, a panel has decided, despite evidence that they could pose serious health risks. An independent advisory panel voted by nine to six to recommend an ending of the restrictions...
Silicon breast implants taken off the US market 11 years ago should be made available to all women who want them, a panel has decided, despite evidence that they could pose serious health risks.
An independent advisory panel voted by nine to six to recommend an ending of the restrictions on the implants.
Usually the food and drug administration, to which the panel reported, accepts such a recommendation. But the narrow vote and continuing concerns about long-term effects means the lifting of the ban may not be inevitable.
An FDA official said a final decision would be made within a few weeks.
The recommendation came after two days of hearings in which some users spoke of pain and health complications after implants, which have been blamed for causing auto-immune disease, cancer and chronic fatigue.
Others, including cancer patients, who had had reconstructive surgery using the implants, favoured their use.
Saline implants are available but some women say they can be uncomfortable.
If the FDA follows the advice restrictions would have to be introduced, meaning that doctors would have to give potential users specific warnings of the risks and the manufacturer, Inamed, would have to monitor the implants' effects.
Inamed is the only manufacturer seeking approval, many competitors having dropped out since restrictions on sale were imposed in 1992.
Under the panel's recommendation Inamed would have to encourage users to have annual tests and have ruptured implants removed.
The firm would also have to train surgeons on how to diagnose ruptures. During the hearing it emerged there was a 1% a year rupture rate.
Inamed, based in Santa Barbara, California, provided the panel with details of a two-year study it conducted on the long-term effects of implants.
Opponents said there was still insufficient evidence to make the implants freely available.
"This was a triumph of wishful thinking over science," said Nancy Zuckerman of the National Centre for Policy and Research for Women and Families.
An independent advisory panel voted by nine to six to recommend an ending of the restrictions on the implants.
Usually the food and drug administration, to which the panel reported, accepts such a recommendation. But the narrow vote and continuing concerns about long-term effects means the lifting of the ban may not be inevitable.
An FDA official said a final decision would be made within a few weeks.
The recommendation came after two days of hearings in which some users spoke of pain and health complications after implants, which have been blamed for causing auto-immune disease, cancer and chronic fatigue.
Others, including cancer patients, who had had reconstructive surgery using the implants, favoured their use.
Saline implants are available but some women say they can be uncomfortable.
If the FDA follows the advice restrictions would have to be introduced, meaning that doctors would have to give potential users specific warnings of the risks and the manufacturer, Inamed, would have to monitor the implants' effects.
Inamed is the only manufacturer seeking approval, many competitors having dropped out since restrictions on sale were imposed in 1992.
Under the panel's recommendation Inamed would have to encourage users to have annual tests and have ruptured implants removed.
The firm would also have to train surgeons on how to diagnose ruptures. During the hearing it emerged there was a 1% a year rupture rate.
Inamed, based in Santa Barbara, California, provided the panel with details of a two-year study it conducted on the long-term effects of implants.
Opponents said there was still insufficient evidence to make the implants freely available.
"This was a triumph of wishful thinking over science," said Nancy Zuckerman of the National Centre for Policy and Research for Women and Families.
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