2602. Misbranding of Gomco ring pessaries.   U. S. v. 17 Devices   *   *   *   (and
1 other seizure action).   (F. D. C. Nos. 25753, 25764.   Sample Nos. 27462-
K, 27464-K, 37644-K.)
LIBELS FILED : On or about September 13 and 30, 1948, Eastern District of Mis-
souri and District of Oregon.
ALLEGED SHIPMENT: On or about March 30, May 24, and July 30, 1948, by the
Gomco Surgical Manufacturing Corp., from Buffalo, N. Y.
PBODTJCT : Gomco ring pessaries. 17 devices at St. Louis, Mo., and 20 devices at
Klamath Falls, Oreg., together with a number of circulars entitled "Gomco
Intrauterine Ring." Examination showed that the device was a metallic ring,
approximately one inch in diameter, which was fashioned from a coiled spring.
NATURE OF CHARGE : Misbranding, Section 502 (j), the device was dangerous to
health when used with the frequency and duration recommended and suggested
in the circulars, namely, "It may be left in the uterus indefinitely. Cases have
been reported in which the ring has been left in position for six years, without
removal and with no ill effect. Pathological Tests Give No Indications of
Malignancy. We would suggest however that the physician withdraw and
place the Gomco Intra-Uterine Ring yearly * * * Technic: (As Suggested
by Haire) 'The Ring Pessary should be inserted during menstrual period in
order that one may be certain that patient is not already pregnant. The
patient is placed in the lithotomy position, a vaginal speculum is inserted by
means of special introducer. There is usually no pain following its introduc-
tion and no pain at the periods. Even in cases where menstruation has been
painful, previously, the presence of the ring seems to diminish it. Technic of
Gomco Intra-Uterine Ring. Gomco Intra-Uterine Ring in Uterus (Diagrams
showing method of inserting Ring and its position in the Uterus)."
Further misbranding, Section 502 (a), the statements in the circulars "The
Gomco Intra-Uterine Ring is used where a * * * safe procedure for con-
traception is indicated" was false and misleading since the device could not
be safely used under any conditions; and, Section 502 (b) (1), the device failed
to bear a label containing the name and place of business of the manufacturer,
packer, or distributor.
DISPOSITION : October 14 and November 5, 1948. Default decrees of condemna-
tion and destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAIL-
URE TO BEAR ADEQUATE DIRECTIONS OR WARNING
STATEMENTS*