Silicone Gel Implant Adjunct Study

21 USC § 331–337 (1953, 1962, 1970), 351, 352 (1988).

Medical Device Amendments of 1976, Pub L No. 94–295, 90 stat 539 (1976), codified at 21 USC § 360c–360k (1988).

21 USC §§ 360 c (c), 360e (b–g) (1988); 21 CFR §§ 814.20–814.46, 860.7, 860.84 (1990).

Proposed Rules, Federal Register, January 19, 1982.

Federal Register Notice, General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices; Final Rule 23856–23877, June 24, 1988.

Kessler DA : The basis of the FDA's decision on breast implants. N Engl J Med 326: 1713, 1992.

21 USC § 360 (e), (d) (1) (B) (i).