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News1994February › Breast implants: safety row › February 1994

Breast implants: safety row

Ignoring mounting evidence of the dangers of silicon gel breast implants, the American Medical Association has endorsed a report recommending their use on an "informed consent" basis

Ignoring mounting evidence of the dangers of silicon gel breast implants, the American Medical Association has endorsed a report recommending their use on an "informed consent" basis.

The Food and Drugs Administration (FDA) restricted the use of implants to controlled clinical trials in 1992 because they did not meet the statutory requirements on safety and effectiveness.

Implants had been marketed for 30 years, and have been used by up to 2 million women in the US alone.

Since the FDA ruling, further reports have linked implants to immune disorders, and a recent Canadian study reports a failure rate as high as 20 per cent.

Even so, the AMA, the representative body of American doctors, has adopted a report from the Council of Scientific Affairs which the association's own journal has condemned as being hopelessly flawed.

In an editorial (JAMA, 1 December, 1993), the journal condemns AMA's position for "using informed consent (as) a means of compensating for poor product performance".

The report also overlooks the "serious failings of physicians and never articulates their responsibility with regard to the safety of medical devices."


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