Date: Wed, 6 Oct 1999 11:45:26 -0500

Organization: TDN

1906 Grant Lane Columbia, MO. 65203

Phone: (573) 445-0861 Fax: (573) 445-8539

------------------------

What the FDA is NOW saying:

-----------------------------------------------

. Preclinical Data - Chemistry

1.1 General Information

A complete list of all of the chemicals used in the manufacture of the breast prosthesis should be provided. The list should include the common names and trade names of each chemical component, the specific role of each chemical in the manufacturing process and/or in the final device. The location of the chemical within the device, e.g., in the shell, the inner or outer layers of the shell, in the filler, valve, or adhesive, should also be provided. Polymeric components should be described by chemical name, mean molecular weight, and a measure of the polydispersity. Material safety data sheets (MSDS) should be provided for each chemical.

2. Chemical Analysis of Elastomer Shell including Patch and Valve

Chemical analyses of the elastomer shell, including the patch and valve, should be provided. The elastomer should be cryoground and analyzed separately from the filler. The cryoground elastomer shell should be analyzed for volatile components; using a headspace detector is one method. Changes in design features, such as texturing, variations of device components such as patches or valves, or changes in sterilization, may necessitate additional analyses to detect variations in chemical composition.

An analysis of the extractable or releasable chemicals of an implant is necessary for the assessment of the safety of the device. The identification and quantification of releasable chemicals should be provided to identify potentially toxic chemicals and estimate the upper limits of the chemicals that could be released to the patient.