Data on increased skin dose due to the ipsilateral cup were submitted to the FDA. These data provided a comparison of skin dose increased by the Treatment Brassiere with the increase found for various thermoplastic positioning devices on the market. The skin dose due to the cup material (0.50 mm thick for small cups to about 0.63 mm thick for very large cups) was found to be substantially less than for other positioning devices. The FDA has issued a 510 (k) Marketing Clearance for the Treatment Brassiere.
Cups are divided into four groups corresponding to small thoraxes (chest breadths from 27 to 32 cm), medium thoraxes (32 to 36 cm), large thoraxes (36 to 42 cm), and extra large thoraxes (over 42 cm).
Cup selection begins by measuring a patient’s chest breadth when supine and wearing her clothing brassiere. This indicates the group containing the right cup for her. The cups of the group (five each for left or right) are removed from the Treatment Brassiere Caddy and the cup making the best fit is selected. (Clothing Brassiere sizes cannot be used for cup selection because of poor correlation between clothing brassiere sizes and breast volumes.)