FDA and TGA (Australia) Information for Women
Saline-filled breast implants (silicone envelopes filled with salt water) were already in use in 1976 when the Food and Drug Administration (FDA) began regulating medical devices. Under this 1976 law, manufacturers could continue selling devices already on the market ("grandfathered"). But the 1976 law made it clear that at some time in the future, FDA would require manufacturers to submit their research data showing that these products are safe and effective. Women need to know that until this call for research data occurs, laboratory, animal, and human tests on some of these "grandfathered" prod ucts-incl uding saline breast implants-may not have been completed by the manufacturer or reviewed by FDA.
Women considering saline-filled breast implants for breast enlargement or reconstruction should receive the following information about implants (and, when appropriate, other options for reconstruction) before surgery is scheduled. This will allow them time to review the material and discuss possible risks and benefits with her doctor. For some women, breast implants can improve their quality of life. Some breast cancer survivors believe that getting implants has been an important part of their recovery. However, other women find external breast forms to be satisfactory. Reconstruction options include breast implants or surgery using tissue from a patient's own abdomen, back, or buttocks to form a new breast. This surgery requires sufficient fat tissue and a longer operation, and like any other procedure, it is not always successful. For each woman, whether her goal is augmentation or reconstruction, the benefits may be different. With her doctor's advice, each woman must decide whether or not she wishes to accept the possible risks in order to achieve the expected results.
Breast implant surgery presents the same general risks associated with anesthesia and any other surgery. After the surgery, there are other special risks related to saline filled or gel breast implants. (The manufacturer's package insert for these devices gives additional, more detailed information. Your surgeon has a copy and can provide it to you).
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TGA (Therapeutic Goods Australia) Reports:
Breast implants are regarded as therapeutic goods under the terms of the Therapeutic Goods Act (1989), which came into effect on 15th February 1991.
With the implementation of the Therapeutic Goods Act (1989), breast implants along with other devices were entered on the Australian Register of Therapeutic Goods (ARTG) as 'grandfather status' low risk (Listable) devices. Entry on the ARTG is necessary to allow legal supply of devices in Australia.
In July 1991, following reports of local and systemic complications and growing concerns regarding their safety, the TGA advised all suppliers of silicone gel-filled breast implants that these devices would be changed from low risk (Listed) devices to high risk (Registrable) devices. Manufacturers and suppliers were informed that adequate data supporting the safety of silicone gel-filled breast implants would need to be supplied to the TGA by 31st January 1992, if they wished to continue marketing these devices.
At the time, no manufacturer or supplier had such information and as a result there were no silicone gel-filled breast implants on the ARTG until 29th June 2001, at which time a manufacturer of silicone gel-filled breast implants satisfactorily demonstrated their quality, safety and efficacy.
Over the last five years numerous large scale studies on the effects of silicone gel-filled breast implants have been conducted. Many of the earlier concerns about silicone gel-filled implants have been resolved and are reflected in this booklet.
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