The Dalkon Shield, the TCu 200, and the TCu 380A in private practice
Thomas, W.O.
Transactions of the Pacific Coast Obstetrical and Gynecological Society 44: 78-85
1977
ISSN/ISBN: 0078-7442 PMID: 335580 Document Number: 435770
A study was conducted to investigate the effectiveness of the Dalkon Shield IUD and of the TCu 200 and the TCu 380A. 151 private patients who used the Dalkon Shield for 24 months, from June 1970 to June 1972, were studied. With the 21% nulliparas, the small Dalkon was used; In the comparative randomized double-blind study of the TCu 200 and the TCu 380A 579 cases were involved; 109 of these were private and 470 were clinic patients. Results are expressed in terms of net cumulative event rates per 100 users. The accidental pregnancy rate for the Dalkon Shield at 24 months was 4.4 (most occurring in the 1st 60 days); for the TCu 200, 1.9; and for the TCu 380A, 0.6. The expulsion rates at 24 months are as follows: the Dalkon Shield, 1.5; TCu 380A, 7.4; and TCu 200, 7.1. At the end of 12 months the number of removals due to bleeding and pain were as follows: the Dalkon Shield, 12.6; clinic patients with TCu's, 15, and private patients with TCu's, 8.2. At the end of 24 months it was 20.7, 24.7, and 21.6 respectively. The incidence of pelvic inflammatory disease was Dalkon Shield, 3.0 with 1 unilateral case, clinic patients with TCu's, 5.8 with 1 unilateral case; and private patients with TCu's, 3.1 with no unilateral cases. No back-up methods of contraception were used. There were 2 tubal pregnancies and no uterine or cerfical perforations. A modification of the method of insertion of the TCu is suggested.