Woman and Silicone Implants

Patients may be asking about FDA's recent decision to approve the marketing of certain silicone gel-filled breast implants. They may want to know more about the safety of these devices, and they may need guidance in deciding whether or not to have them. The approved implants are made by two companies, Allergan and Mentor. They're approved for breast reconstruction in women of all ages, and for breast augmentation in women 22 and older. FDA is requiring that the companies continue to study the safety of the implants for about 10 more years after they are marketed. Each company will study about 40,000 women, and this can give more information about possible rare adverse effects. A report by the Institute of Medicine several years ago concluded that there was no convincing scientific evidence that women with the implants are at greater risk for systemic problems like increased risk of neurological disorders, connective tissue diseases and cancer, and other studies have borne that out. But this question will continue to be addressed in the long-term studies that will be conducted by the companies. FDA Patient Safety News: January 2007. Brought to you by SafetyTV Library, www.safetyissues.com. Life Has No Reset Button, Think Safety.