Lost in all the excitement over the US Food and Drug Administration’s (FDA) decision to reapprove silicone gel breast implants has been the requirement to continue studies on the safety of these products.
FDA’s decision to approve the implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies, and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. The FDA also conducted inspections of each company’s manufacturing facilities to determine that they comply with its Good Manufacturing Practices.
In the past decade, many independent studies have examined whether silicone gel–filled breast implants are associated with connective-tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these types of diseases. However, these issues will be addressed further in the postapproval studies conducted by the companies.
FDA approved the implants with several conditions, including requiring each company to conduct a postapproval study by following about 40,000 women for 10 years after they receive breast implants; continue its core study through 10 years; conduct a focus-group study of patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant sold in the event—for example—that health professionals and patients need to be notified of updated product information.
The postapproval studies will continue to gather information about the safety and effectiveness of the implants. Information will be collected about:
• rates of local complications;
• rates of connective tissue disease and its signs and symptoms;
• rates of neurological disease and its signs and symptoms;
• potential effects on offspring of women with breast implants;
• potential effects on reproduction and lactation;
• rates of cancer;
• rates of suicide;
• potential interference of breast implants with mammography; and
• MRI compliance and rupture rates.
The postapproval studies will be closely monitored by the FDA. The agency anticipates that data from the studies will provide important information for patients and physicians, and may lead to improvements in device labeling.
[www.fda.gov, November 17, 2006]