FDA warns of risks from breast implants
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《英国医生杂志》
Women considering breast augmentation should be aware of the risk of implants rupturing and other adverse events during mammography.
Delayed detection of breast cancer and pain and discomfort are among the other risks identified in an analysis of reports received by the Food and Drug Administration.
揑t is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants,?say the authors, from the FDA抯 Division of Postmarket Surveillance.
In the study, reported in the Journal of Women抯 Health (2004;13:371-8), the authors searched the FDA抯 database of adverse events for reports concerning silicone gel breast implants or saline breast implants.
They found 66 reports from more than 10 years detailing adverse events that occurred during mammography or that described interference with mammography by breast implants.
Forty one of the reports described rupture of breast implants during mammography. Other adverse events reported included implants crushed by mammography, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer blamed on implants. There were also reports that breast tissue had become either soft or hard after mammography.
揙ther problems reported were related to mammography performance or interpretation because of implants. These included claims of delayed or missed diagnosis of cancer because tissue was obscured by the implants,?write the authors.
揑n several cases reported to the FDA, a delay in detecting cancer with mammography was attributed to the patients?implants. From 22% to 83% of mammographically visualisable breast tissue may be obscured by breast implants because radiodense silicone implants obscure glandular tissue.?/p>
In one case detailed by the authors the patient reported that six days after mammography she woke up with pain in her breast. The breast implant had caved in and a large blood clot had formed the between implant and scar tissue.
In another case, detection of a 51 year old woman抯 cancer had been delayed because of silicone breast implants. Five cancerous tumours, ranging from 0.5 cm to 2 cm, were not shown in two sets of mammograms and xeromammograms carried out within 10 days of each other.
揝he has had removal of her breasts and ovaries, radiation, chemotherapy, and a bone marrow transplant to save her life,?says the report.
The FDA approved saline breast implants in 2000, but silicone gel breast implants have never been approved by the FDA and are currently available only in clinical studies restricted to women undergoing breast reconstruction or revision or to a limited number of women for cosmetic augmentation.(Abergavenny Roger Dobson)
Delayed detection of breast cancer and pain and discomfort are among the other risks identified in an analysis of reports received by the Food and Drug Administration.
揑t is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants,?say the authors, from the FDA抯 Division of Postmarket Surveillance.
In the study, reported in the Journal of Women抯 Health (2004;13:371-8), the authors searched the FDA抯 database of adverse events for reports concerning silicone gel breast implants or saline breast implants.
They found 66 reports from more than 10 years detailing adverse events that occurred during mammography or that described interference with mammography by breast implants.
Forty one of the reports described rupture of breast implants during mammography. Other adverse events reported included implants crushed by mammography, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer blamed on implants. There were also reports that breast tissue had become either soft or hard after mammography.
揙ther problems reported were related to mammography performance or interpretation because of implants. These included claims of delayed or missed diagnosis of cancer because tissue was obscured by the implants,?write the authors.
揑n several cases reported to the FDA, a delay in detecting cancer with mammography was attributed to the patients?implants. From 22% to 83% of mammographically visualisable breast tissue may be obscured by breast implants because radiodense silicone implants obscure glandular tissue.?/p>
In one case detailed by the authors the patient reported that six days after mammography she woke up with pain in her breast. The breast implant had caved in and a large blood clot had formed the between implant and scar tissue.
In another case, detection of a 51 year old woman抯 cancer had been delayed because of silicone breast implants. Five cancerous tumours, ranging from 0.5 cm to 2 cm, were not shown in two sets of mammograms and xeromammograms carried out within 10 days of each other.
揝he has had removal of her breasts and ovaries, radiation, chemotherapy, and a bone marrow transplant to save her life,?says the report.
The FDA approved saline breast implants in 2000, but silicone gel breast implants have never been approved by the FDA and are currently available only in clinical studies restricted to women undergoing breast reconstruction or revision or to a limited number of women for cosmetic augmentation.(Abergavenny Roger Dobson)