Probe into implants over link to cancer
Source: Agencies |
January 28, 2011, Friday
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Print Edition
Print Edition
UNITED States government health officials are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinized for decades.
The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and skin and has been reported in the scar tissue which grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.
The agency is aware of just 60 cases of the disease worldwide among the estimated 5 million to 10 million women with breast implants. The agency reviewed the -scientific literature going back to 1997 along with information provided by -international governments and manufacturers.
Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.
Because the disease is so rare, FDA researchers suggested the issue may never be completely resolved.
"A definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established," the agency said.
Still, the FDA said it is working with the American Society of Plastic Surgeons to register patients with the cancer and track them over a period of time.
Breast implants come in both saline and silicone-gel filled formulations and are marketed in the US by -Allergan Inc and Johnson & Johnson's Mentor Corp. Those companies will be -required to update the labeling for their products to reflect the cancer cases.
The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and skin and has been reported in the scar tissue which grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.
The agency is aware of just 60 cases of the disease worldwide among the estimated 5 million to 10 million women with breast implants. The agency reviewed the -scientific literature going back to 1997 along with information provided by -international governments and manufacturers.
Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.
Because the disease is so rare, FDA researchers suggested the issue may never be completely resolved.
"A definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established," the agency said.
Still, the FDA said it is working with the American Society of Plastic Surgeons to register patients with the cancer and track them over a period of time.
Breast implants come in both saline and silicone-gel filled formulations and are marketed in the US by -Allergan Inc and Johnson & Johnson's Mentor Corp. Those companies will be -required to update the labeling for their products to reflect the cancer cases.
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