Contraceptive Research, Introduction, and Use Lessons From Norplant (1998) / Chapter Skim
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2 Workshop Report
2 Workshop Report
Pages 3-36
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From page 3... ...
(Presentation 1) · 5-year Population Council studies of women using Norplant and women using the two-rod levonorgestrel implant system (LNG ROD)
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From page 4... ...
Table 2-1, provided to the subcommittee after the workshop as additional detail for purposes of comparison, presents data on first-year and 5-year pregnancy rates for Norplant and the LNG ROD Dom studies in 14 countries. The evidence from those studies and from the new data presented at the workshop was that both Norplant and two-rod levonorgestrel implant system are highly efficacious, with failure rates under 1 percent per year, thus providing reversible contraceptive protection essentially equal to that of permanent methods tubal ligation and vasectomy.
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From page 5... ...
5 c~ cd e s~ o : o c~ 'e o .~ 'e · ~: o c: 'e u)
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Mood disturbances were recorded more, frequently among Norplant users than among IUD users, but their incidence was similar to that generally found with other hormonal methods of contraception. In fact, the presenter commented, noting that the observation was likely to be controversial, that Norplant appears to produce patterns of adverse effects very similar to those of combined oral contraceptives (COCs)
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From page 7... ...
There was also agreement that the Postmarketing Surveillance of Norplant was valuable not only as a source of knowledge on side effects not identified in clinical trials, but as evidence that large-scale, longer-tenn studies using cohort methodology can now be considered feasible in developing countries. Silicone Biocompatibility The possibility of association between silicone-/gel-filled breast implants and connective tissue or autoimmune disease has stimulated questions about other implants, including contraceptive implants, that employ other silicone materials.7 Two workshop presentations (3 and 4)
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From page 8... ...
In sum, the Norplant implant system uses amorphous silica rather than the crystalline silica alleged to have been associated with problems, and there is no evidence that this silicone rubber is implicated in any immunologic response, even though there will be an inflammatory reaction, as to any foreign body. The presenters agreed that a matter of great concert,, one that could conceivably affect the supply of biomaterial for implant contraceptives, is the current controversy and litigation over silicone products.
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From page 9... ...
. In all countries included in the Surveillance, women opting for sterilization had less education than those opting for either an IUD or Norplant, and women opting for Norplant had less education than IUD users, the exception to the latter was South America, where IUD and Norplant users had similar educational levels.
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From page 10... ...
Women aged 20-24 were the largest group of users, representing 4 percent of all women using reversible contraceptive methods and a little under 4 percent of all women contracepting. Women aged 15-19 were proportionally the next largest group, followed by women aged 25-29.
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From page 11... ...
Method Continuation and Discontinuation In addition to pregnancy rates, Table 2-1 summarized the Norplant continuation rates from 14 countries and, for three of those countries, continuation rates for the LNG ROD. First-year continuation rates were high for all countries, ranging from 76.0 in Scandinavian countries to 97.6 in Thailand.
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From page 12... ...
And, while explicitly comparative data are also scanty, continuation rates for the implant are high compared to those for other reversible methods. Side Effects as Factors Side effects have been generally considered major contributors to Norplant discontinuation, so that it was not surprising that the women in the Columbia and RTI/Emory/CMC studies said that what they liked least about Norplant were its side effects.
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From page 13... ...
In the RTI/Emory/CMC sample, at 12 months, while both menstrual and nonmenstrual side effects Tom Norplant each increased discontinuation, discontinuation attributed by women to nonmenstrual side effects was higher. The RTI/Emory/CDC study examined the frequency of Norplant-related side effects relative to other contraceptive methods and found that nearly all Norplant users reported one or more side effects, as was the case for women using DepoProvera; considerably fewer women using oral contraceptives (OCs)
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Several participants commented that what seems to be happening is that women who stay with Norplant seem motivated to trade off side effects, even when burdensome in number or severity, for the convenience and efficacy they believe essential to greater control over their lives. Barriers to Discontinuation Norplant continuation rates may be high relative to other methods simply because a surgical intervention is required for discontinuation, unlike DepoProvera and the pill which users can stop of their own accord.
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From page 19... ...
A "savings" model was developed for the United States that calculated a total cost for each of 15 categories of reversible and irreversible contraceptives and the costs of pregnancies resulting from contraceptive failure based on the four possible unintended pregnancy outcomes spontaneous abortion, ectopic pregnancy, induced abortion, or birth each in the proportion expected nationally in the United States. All costs were derived from a state Medicaid schedule of benefits and compared to a private payer database.
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From page 20... ...
In the array of individual method costs and associated savings, whose rank order is driven largely by their relative failure rates, by their consequences in the form of unintended pregnancy, and by the high price of pregnancy, the implant ranks very high in cost-effectiveness relative to other contraceptive methods, saving $13,813 over a S-year period of use. This is the case even for younger users, for whom a pregnancy prevented is typically delayed rather than averted (in which instance savings are reduced)
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From page 21... ...
Figure 2-1 is an attempt to sort out these differing perceptions by tracking patterns of Norplant insertions, women's opinions about the method, events in the courts, and media coverage. The figure shows coincidence among decline in method adoption, negative attitudes, legal actions, and media coverage of those actions.
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From page 22... ...
Other pertinent data come Mom the Ortho Birth Control Survey, data that could not, for mechanical reasons, be well reflected in Figure 2-1. In 1994, of the Oreo sample of women aged 15-50, 34 percent had had a favorable opinion of Norplar~t, with 16 percent viewing it unfavorably.
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From page 23... ...
For all methods, removal proceeds following injection with a local anesthetic near the base of the fare of capsules. The U technique, developed and evaluated in Indonesia as a possible alternative method, was described as requiring less manual dexterity than the other two methods, as well as less training time for acquisition of sustained competency; it also was reported to produce fewer removal problems and shorter removal times.
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From page 24... ...
Another and very crucial element of success would be training not only for insertion but for removal because, beyond the progestin-related side effects of the implant's contents, the program designers anticipated that implant removal would be a significant issue. The program first trained a small core group of senior trainers on site in Indonesia and then used them to precipitate a "cascade" of training and oneon-one supervised clinical practice for selected providers in 35 training centers nationwide.
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From page 25... ...
The rate in the Population Council studies was 2.6 percent for both Norplant and the LNG ROD. Both rates are low compared to the removal complication rate of 6.2 percent in clinical trials that appears in the product labeling.2' As some workshop participants noted, the Surveillance studies and the non-randomized Population Council studies were conducted in family plannin, clinics chosen for their good quality, all of which had had experience with Norplant and were familiar with both insertion and removal procedures.
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From page 26... ...
As observed earlier, while one-third of the Norplant users identified by the NSFG obtained the method through family planning clinics, two-thirds obtained it from a miscellany of sources. In neither country is there a legal way to prevent any physician who wishes to do so from inserting or removing the implant.
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From page 27... ...
The panelists described a continuum that would span appropriate arid intelligible product labeling, and · provider Raining, including collaboration in initial method choice, This section summarizes perspectives presented by Katz, Macklin, Moskowitz, Pearson, Scott, and Secundy, interwoven with perspectives from the workshop group as a whole.
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From page 28... ...
They added that the medical system's role in sustaining contraception that is, helping women stay on a method yet change freely as appropriate would, ideally, integrate contraceptive counseling into reproductive health care, including sexual health, and more broadly into comprehensive medical care. For both Norplant and the LNG ROD, this entails special attention during the first 6 to 9 months when bleeding patterns are most irregular, as well as thoughtful, open response if removal becomes necessary.
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From page 29... ...
Participants also noted the need for ongoing review-by manufacturers, providers, and system managers to ensure that information critical to method choice is provided in appropriate formats. The discussion centered on how to adapt such information to account for differences in educational levels, language, socioeconomic status, and stage of the reproductive life span, and on the need for innovative methodologies such as modern commercial marketing techniques and focus-group approaches to accomplish this.
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From page 30... ...
Potentialfor Abuse il il There was much discussion of legislative and judicial attempts in the United States beginning in 1991 to utilize Norplant coercively: by mandating' its use as a condition of probation in cases of child abuse, making it a precondition for access to welfare payments, or offering financial incentives to welfare recipients to adopt it.25 None of these efforts succeeded. However, because they had focused primarily on poor, single women, often black or Hispanic, they had evoked memories of other, previous attempts to restrict reproductive freedoms that had disproportionately affected minority women.
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From page 31... ...
The WHO strategy approaches the full range of health system constraints to appropriate introduction and delivery of contraceptives. The Government Standards Defense offers a possible mechanism for dealing with the pressures of product liability on innovation in contraceptive research and development.
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From page 32... ...
Both parts of the cycle have obstructed realistic, nuanced, data-based understanding, of product strengths and limitations, and the costs are high: diminished contraceptive choices; health problems for women using products inappropriately; negative impact on the financial well-being of companies; discouraged investment in contraceptive research and development; and a climate of mistrust and lack of confidence about the introduction and delivery of new contraceptive products which affects researchers, providers, and consumers. The Initiative's goal is to engage key players sometimes adversaries in this cycle, in collaborative efforts to interrupt it.28 The basic belief is that shared interest in meeting the contraceptive and reproductive health needs of consumers can motivate a diverse group to action, despite divergent views.
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From page 33... ...
In the latter respect, the objectives of the program are similar to those described for Reproductive Health Technologies' "Boom and Bust Initiative." While the presentation did not propose that this new strategy would be a panacea, it did conclude that the approach has so far proven
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From page 34... ...
A "Government Standards Defense" In its 1996 report,30 the IOM committee reiterated the recommendation of the 1990 National Research CouncillIOM contraceptive research and development committee that the U.S. Congress enact a federal product liability statute that would make FDA approval of contraceptive drugs and devices available to contraceptive manufacturers as a defense against punitive damages, assuming proper compliance with FDA regulatory requirements.
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From page 35... ...
Both IOM committees noted that because a regulatory standards defense would necessarily interact with postmarketing surveillance efforts, any recommendation for such a statute would be more compelling were formal postmarketing surveillance studies to be an integral and general requirement. As for the general wisdom that liability relief would be an incentive to contraceptive research and development, the proof that it has been a disincentive cannot be gotten through any retrospective study that could be called scientific, so that it must be tested prospectively in the doing.
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