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Breast implants: safety row

01 February 1994

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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Ditch those implants - Silicone-gel breast implants and other silicone prostheses may cause arthritis-like symptoms such as swelling of joints, pain, fever and chronic fatig...

Fda to doctors: open up or else - America's health regulator, the Food and Drug Administration (FDA), has been trying for 20 years to get doctors to share more information about drugs...

Drug ads of the month - Capitalizing on the recent congressional pressure and guidelines adopted by the American Medical Association about drug company inducements for doctor...

Drugs: Throw them out with the cat litter - We all know prescription drugs are dangerous – so how best to dispose of them when you get them home from the pharmacy? The prestigious Journal of the...

Silicon ban lifted by uk - Despite the America's Food and Drug Administration's call for a halt to silicon breast implants, Britain has lifted the ban on breast implant operatio...

Drug Controls: The FDA tries to get tough - America’s drug regulator, the Food and Drug Administration (FDA), is finally trying to toughen up its act.

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