Contraceptive Research, Introduction, and Use Lessons From Norplant (1998) / Chapter Skim
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Appendix B: Norplant: Historical Background
Appendix B: Norplant: Historical Background
Pages 107-114
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From page 107... ...
Norplant was the first implantable contraceptive introduced onto the world market, but over progestin-only implant systems have been developed more or less in parallel, differing in He biomaterial used for the delivery system, steroid contents, number of implanted rods or capsules, primary mode of action, and duration of efficacy. None of these implant systems is yet on the market in any coun~y.3 Only one the LNG ROD, a two-rod levonorgestrel implant system, informally referred to as ''Norplarlt-2'' has been approved by the Food and Drug Administration (FDA)
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From page 108... ...
The two-rod system was actually to have been the first implant launched on the U.S. market but, while trials were under way, the supplier ceased manufacture of the elastomer used in the core of the Norplant-2 implant and a change of plans was required.5 Definitions of advantages and disadvantages of any contraceptive method are partly subjective, dependent as they are on individual physiology and context but, in general, the inherent advantages and disadvantages of progestin implants as a contraceptive category are as follows: · Advantages: extremely high efficacy; estrogen-free protection; low and stable blood level maintenance; freedom from need for daily compliance; rapid return to previous fertility; no interference with coitus; no manipulation of genital area; easy palpation; and long duration of action.
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From page 109... ...
1982 Phase II/III studies begin in the United States Another multinational Phase III clinical trial begins in Chile, Dominican Republic, Finland, Sweden, and the United States (PC/ICCR) 199~1995 Phase III clinical trials of soft tubing Norplant capsules and relbrm:~lated Norplant with two rods in Chile' Dominican Republics Egypt Finland, Singapore, Thailand, United States Preintroduction Studies in 30 Countries (start dates)
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From page 110... ...
in one large country site where lack of appropriate provider training and counseling about side effects had contributed to declining interest and discontinuation of use; second, to incorporate greater awareness of user perspectives toward voluntary arid informed choice; and third, to ensure that family planning programs would be able to deliver services properly. The introduction strategy focused on: l ~ developing local experience with the method through preintroduction trials aimed at offering firsthand experience to clinicians; 2)
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From page 111... ...
On August 8, the Texas Supreme Court issued an order indefinitely delaying the trial set for August 11 that was to hear the suits brought by eight Texas women against Wyeth-Ayerst, so that the court could consider a motion by Wyeth attorneys to have several plaintiffs' attorneys disqualified for alleged misconduct.'~ While the principal defendant has been American Home Products and/or its subsidiary, Wyeth-Ayerst Laboratories, there have been suits against individual physicians and health care providers (including Planned Parenthood) involved in insertion or removal of the implant and/or treatment; manufacturer Leiras Oy or its parent company, Huhtamaki oy;~3 Dow Corning or other Dow entities supplying the silastic tubing; Schering AG, the European supplier of bulk levonor~estrel; and the Population Council.
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From page 112... ...
For example, Norplant produces thickening of the cervical mucus that impedes sperm penetration, the mode of action that seems to contribute most to its high efficacy; this effect is much weaker with Nestorone, whose primary effect appears to be ovulation prevention (World Bank/Population Council/World Health Organization Special Program on Research, Development, and Research Training in Human Reproduction. International Consultation on Contraceptive Implants [unpublished paper]
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From page 113... ...
In issuing its ruling, the court applied the learned intermediary doctrine, which holds that when a manufacturer sells a drug that is properly prepared and accompanied by proper directions and warnings to the prescribing physician (the "learned intermediary") , the drug is not viewed as defective or unreasonably dangerous and the manufacturer is neither liable Or resulting damages nor responsible for warning each patient directly (RA Schell.
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From page 114... ...
The case was delayed so that the court could consider a notion by Wyeth attorneys to have several plaintiffs' attorneys disqualified for alleged misconduct (Court delays trial's start in Norplant case, Houston Chronicle, 8 August l 997~ online http://www.chron.com/content/chron...politan/97/08/09/norplant.2-0.htm l)
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