Little wonder that many women–and the committee–believe it is time for the physical and chemical characteristics of implants to be spelled out, with clear-cut information made available on existing implants and standards imposed to ensure that future changes are made only when a thorough investigation shows no possible complications or other harmful effects on safety and health. Specifically,

  • A standard consent procedure should be developed in which women would get information they need, including the possibility of local complications, before making an informed decision to have breast implant surgery.

  • Accepted standards should be determined for concentrations of silicone within the body, whether an implant is present or not.

  • An agreed-upon scientific approach is needed to approve any changes in the composition of silicone implants.

Areas Needing Additional Research

The IOM committee also assessed areas in which more research is needed before the safety of silicone breast implants can be fully understood. These include the following:

  • ongoing studies of women with silicone-based breast implants to define and standardize their physical and chemical characteristics; such studies should include tracking the outcome in women with specific types of implants, such as silicone gel and saline, and the results of these studies should be communicated to women and their doctors;

  • studies of local complications, including frequency of rupture, deflation, and severe contracture;

  • research and evaluation of the use of diagnostic tests for ruptures in women without any symptoms and whether these asymptomatic ruptures need to be removed;

  • evaluation of silicone and silicon amounts in saline implants;

  • the accumulation of more data on saline implants;

  • controlled studies on the use of steroids to reduce some local complications if that is to be considered (steroids are not approved by the FDA for use in breast implants, and their uncontrolled use may damage breast tissue and weaken the implant); and

  • a comparison of stage of cancer detected by mammography in women with and without breast implants.

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