The FDA has set strict conditions in furthering their "insurance" of making sure their decision on lifting the ban on silicone implants was the right decision. Many may feel the conditions are tough, but the FDA is doing the right thing. Prior to the ban, the pressure of the media and society to bring down silicone implants was immense, and the FDA is doing what it can to make sure that safety and prevention is carried out as a primary concern.The following was taken from the FDA:
The FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to
- conduct a large post approval study
- continue its core study through 10 years
- conduct a focus group study of the patient labeling
- continue laboratory studies to further characterize types of device failure
- track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.
The post approval 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 FDA will closely monitor the post approval studies. The agency anticipates that data from the studies will provide important information for patients and physicians, and may lead to improvements in device labeling.
For more information on silicone breast implants visit Breast Implants USA.
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