Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety
A recent paper in the Annals of Surgery has looked at the long-term outcomes of breast implants in approximately 100,000 patients as part of the post approval studies.
This study suggested silicone implants may be associated with an increased risk of certain risks, although the study itself has a number of serious methodological flaws. The paper has been extensively discussed and the potential for media misrepresentation highlighted.
Attached is the statement from Binata Ashar, MD of the FDA’s Centre for Devices and Radiological Health with regards to the study on breast implant safety. The statement contains a link to the original paper and editorial commentary which is open access.
The ABS/ BAPRAS continue to support the National Breast Implant Registry and urges all its members to consent patients for entry. The National Breast Implant Registry will hopefully provide information in the future which can be used to improve the quality of care for all patients and provide information on any potential complications in a prospective manner.
Find the full statement here
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