RECOMMENDATIONS

The committee made recommendations in three general areas:

  1. health matters of importance to women and their physicians;

  2. the need for standard procedures in informing women about breast implants, conducting studies on their safety, and approving changes in design; and

  3. topics in need of more research.

Health Matters

  • All women in the age and risk groups for which mammograms are recommended should continue to have them. Women who have increased risk factors should follow a schedule based on their doctors' recommendation. Regular mammograms are especially important as women grow older because most breast cancer occurs in women over 50.

  • Mothers with breast implants for augmentation should try to breast-feed their babies. Breast-feeding is good for the baby and cannot harm the mother.

  • Strong evidence indicates that placement of implants behind the chest muscles improves mammography performance and lessens the chance for local complications and repeat operations.

  • The committee does not recommend closed capsulotomy as a treatment for capsular contracture.

The Need for Standards

Women often cannot identify the type of implants they have and frequently have received insufficient information before making a choice about them. In the case of some older implants, there may be no surviving information about the model in question. In the early days of silicone implants, some models were custom-made for individual plastic surgeons (who patented their devices). Such implants were sometimes used without any testing. In addition, some companies produced small quantities of unusual implants.

Competition was keen in the implant business and, without any regulation, sometimes both testing and medical and/or company records fell by the wayside. Because of the lack of historical data available, some case reports describing local and systemic complications do not have information on the implant make and models involved.

U.S. implant manufacturers have changed names, been bought out, merged, become part of national and international conglomerates, or gone into bankruptcy. Many foreign implants were also introduced in the United States. Today, however, there are only two companies–Mentor and McGhan Medical–making and selling implants in the United States.



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R E C O M M E N D A T I O N S The committee made recommendations in three general areas: health matters of importance to women and their physicians; 1. the need for standard procedures in informing women about breast implants, 2. conducting studies on their safety, and approving changes in design; and topics in need of more research. 3. Health Matters ✜ All women in the age and risk groups for which mammograms are recommended should continue to have them. Women who have increased risk factors should follow a schedule based on their doctors’ recommendation. Regular mammograms are especially important as women grow older because most breast cancer occurs in women over 50. ✜ Mothers with breast implants for augmentation should try to breast-feed their babies. Breast-feeding is good for the baby and cannot harm the mother. ✜ Strong evidence indicates that placement of implants behind the chest muscles improves mammography performance and lessens the chance for local complica- tions and repeat operations. ✜ The committee does not recommend closed capsulotomy as a treatment for capsular contracture. The Need for Standards Women often cannot identify the type of implants they have and frequently have received insufficient information before making a choice about them. In the case of some older implants, there may be no surviving information about the model in question. In the early days of silicone implants, some models were custom-made for individual plastic surgeons (who patented their devices). Such implants were sometimes used without any testing. In addition, some companies produced small quantities of unusual implants. Competition was keen in the implant business and, without any regulation, some- times both testing and medical and/or company records fell by the wayside. Because of the lack of historical data available, some case reports describing local and systemic complications do not have information on the implant make and models involved. U.S. implant manufacturers have changed names, been bought out, merged, become part of national and international conglomerates, or gone into bankruptcy. Many foreign implants were also introduced in the United States. Today, however, there are only two companies—Mentor and McGhan Medical—making and selling implants in the United States. 24

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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 possi- ble 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 with- out 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. 25