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Your search found 25 Results

  1. 1

    Buyer beware [editorial]

    Nelson AL

    Contraception. 2009 Dec; 80(6):495-6.

    This editorial addresses the issue of increased prices for IUDs over the last several years as demand has grown. It also discusses the problem of web sites offering low prices on IUDs that are not FDA approved.
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  2. 2
    Peer Reviewed

    More women are looking at intrauterine devices.

    Contraceptive Technology Update. 2004 Nov; 25(11):[3] p..

    Are more women at your family planning facility requesting information on intrauterine contraception? Chances are you are seeing an increase in interest: Almost 30% of respondents to the 2004 Contraceptive Technology Update Contraception Survey say they have performed six to 25 intrauterine device (IUD) insertions in the last year, up slightly from 2003’s figures. The popularity of the levonorgestrel intrauterine system (Mirena IUS, Berlex Laboratories, Montville, NJ) led to an increase in the number of IUD insertions, confirms Joe Childress, MD, an obstetrician/ gynecologist in private practice in San Antonio. Women in the United States have two choices when it comes to intrauterine contraception: the Mirena and the Copper T 380A IUD (ParaGard, FEI Women’s Health, North Tonawanda, NY). More IUD insertions are being performed at the Pinal County Health Department, a public health facility in Florence, AZ, reports Carolyn Brown, RNP, nurse practitioner. The facility uses ParaGard IUDs. (excerpt)
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  3. 3

    Triton quarterly analysis of FOF [Family of the Future] plans, fiscal report and funding request for September-November 1981 (Quarter 3).

    Triton Corporation

    Washington, D.C., Triton, 1981. 28 p. (Contract No. NEB-0029-C-1037-00, Egypt)

    The report details plans for the activities and expenditures related to the promotion and sale of contraceptive devices in Egypt for the 3rd quarter of 1981. Family of the Future (FOF) is a nongovernmental agency which operates on a US Agency for International Development grant of $27,200. Major activities from the previous quarter are summarized and plans for each of the 6 FOF departments are provided. The Medical Promotion and Distribution department will develop distribution strategies including locating new cities and establishing sales targets for IUDs, condoms, and spermicides; prepare information booklets for doctors and pharmacists on devices as they are added to the product line; and oversee warehousing details and sponsor conferences for pharmacists and doctors. These activities are expected to consume 25.6% of the proposed budget. The advertising and art department will determine communication strategies for all products. Copy and time slots will be suggested for mass media promotion of FOF and of available family planning methods to be aired on television stations and 6 radio stations. Inserts for 6 newspapers, 7 weekly magazines, 5 bi-monthly or monthly magazines, and 4 special audience publications will be prepared. This department will operate on 31.3% of the budget. Other promotional activities will include the design and production of multi-product countertop displays and of giveaway items. The medical and scientific department will sponsor a symposium for influential university affiliated obstetricians and gynecologists from 4 cities to stimulate interest in family planning and in FOF and its products. Training programs on IUD insertions will be provided. Volunteers and social affairs departments will use 25 volunteers to organize 110 rallies reaching 2500 people each that are gathered in crowded places or through door-to-door contact. Volunteers will also continue to collect interview data. Volunteer training is planned to target seasonal vacation areas. Samples of condoms and spermicides, booklets, and pamphlets will be distributed during upcoming festivals. A central location will be established from which volunteers can answer questions. The market research department plans to conduct 19 group sessions and continue data collection for the pharmacy intercept study. Market research training in the US is arranged for an FOF employee. No changes are planned which would affect the administration department. A detailed financial analysis of quarterly projections and expenditures is provided. Revenues from sales of contraceptive devices are also included in the report. An evaluation of the planned activities and recommendations for additional activities are detailed.
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  4. 4

    Intrauterine contraceptive devices: uniform labelling regulation.

    Bureau of Medical Devices and Diagnostic Products

    Silver Spring, Maryland, 1979.. 5.

    As a result of both FDA's review of IUD labelling in the United States and a public hearing on IUD use conducted by an Ad Hoc Obstetric-Gynecology Advisory Committee, FDA announced effective November 7, 1977 new patient and physician labelling requirements for IUDs. The information contained in a patient brochure developed by IUD manufacturers includes both pre- and postinsertion facts describing the effectiveness of IUDs, in addition to directions for use, side effects and contraindications. Warnings are also listed particularly cautioning about pregnancy with an IUD in situ. Physicians received similar detailed information including use-effectiveness data along with communication stressing the need for patient counseling and evaluation. The new requirements are intended to aid both physicians and patients in making informed decisions and choices concerning IUD use.
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  5. 5

    Distribution of contraceptives in the commercial sector of selected developing countries. Summary report.

    Westinghouse Population Center

    Columbia, Maryland, Westinghouse Population Center, Health Systems Division. 1974 Apr; 135.

    The role of the commerical sector in delivering contraceptive products (primarily the pill and condom) is examined in the following 8 developing countries: Turkey, Iran, Thailand, Korea, the Philippines, Venezuela, Panama, and Jamaica. Current status of distribution was obtained from surveys of fertile couples. Recommendations are given for action at both the national and international level: an illustrative marketing plan for increasing commercial distribution is presented. The commerical sector is considered a needed component in helping to meet national population policies; it is suggested that governments and donor agencies help eliminate barriers to increased commercial distribution, and that commercial companies cooperate with these organizations. Major findings are detailed by examining the distribution systems, marketing activities, pricing policies, and consumer attitudes, knowledge and behavior. Major factors which impede or facilitate contraceptive usage and current commerical distribution are given for each country.
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  6. 6

    New labeling for contraceptives -- STDs.

    CONTRACEPTION REPORT. 1993 Nov; 4(5):14.

    In 1993, the Food and Drug Administration (FDA) issued new labeling guidelines for oral contraceptives, intrauterine devices (IUDs), implantable and injectable contraceptives, and natural membrane condoms. The prevalence of sexually transmitted diseases (STDs) and the AIDS epidemic prompted the FDA to take this action as part of an on-going education effort to reduce the risk in sexually active individuals, particularly adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults, are continuing to engage in high-risk sexual behavior. The required statement for oral contraceptives, subdermal implants, injectables, and IUDs is: "This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases." For latex condoms the message reads: "If used properly, latex condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." For female condoms the label reads: "If you are not going to use a male latex condom, you can use a female condom to help protect yourself and your partner." The message on latex condoms will appear on individual condom wrappers as well as on the outer package. Manufacturers will add a similar statement to patient and physician leaflets provided with the products. Other contraceptives that may be relabeled in the future include spermicides, cervical caps, diaphragms, and the contraceptive sponge. The new contraceptive labeling effort is part of a broader initiative of the US Public Health Service regarding women's health that focuses on health issues and diseases in women, including reproductive disorders, breast and other cancers, and substance abuse.
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  7. 7

    New labeling to provide information about contraceptives and STDs.

    FDA MEDICAL BULLETIN. 1993 Jun; 23(2):4-5.

    The US Food and Drug Administration (FDA) has notified the manufacturers of oral contraceptives, IUDs implantable and injectable contraceptives, and natural membrane (lambskin) condoms that labeling accompanying their products must state in clear language displayed prominently that they do not provide protection from sexually transmitted diseases (STDs) including AIDS. FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other STDs in sexually active individuals, particularly adolescents and young adults. Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Oral contraceptives, Norplant, Depo Provera, natural membrane (lambskin) condoms, and IUDs are intended to prevent pregnancy and do not protect against HIV infection (AIDS) and other STDs. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. This message is to appear on individual condom wrappers, as well as on the outer package. FDA, is conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom should be changed as well.
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  8. 8

    The use of private sector marketing research techniques in CSM projects in the developing world.

    Tipping S

    [Unpublished] 1989. Presented at the IIDSS Conference, August 18-20, 1989. [15] p.

    The author explains the operations of and rationale behind the Social Marketing for Change (SOMARC) project of the Futures Group. Using indigenous private sector company commercial channels in developing countries, SOMARC helps develop advertising campaigns and other marketing approaches to sell branded condoms, oral contraceptives, vaginal foaming tablets, and sometimes IUDs. Commercial marketing research techniques are employed in these exercises, and include developing and evaluating advertising and marketing strategies, designing and testing advertising messages, and selecting and improving product names and packaging for their contraceptive products. Although technical assistance is generally required in most countries, local companies are nonetheless depended upon to develop and manage the projects overall. The importance of brand image research in reaching target markets is discussed, followed by examples of testing and evaluating marketing strategies, product names, package testing, and advertising messages.
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  9. 9

    Contraceptive social marketing training program.

    Futures Group. Social Marketing for Change [SOMARC]

    [Washington, D.C.], Futures Group, SOMARC, [1987]. iv, 147 p.

    This training manual in social marketing of contraceptives (CSM) in text format presents the elements of a program, summarizes marketing theory, and describes practical examples. It is based primarily on written material by marketing professionals and population communication experts. The elements of social marketing, elaborated in 10 chapters, include: marketing, products selection, pricing, promotion, distribution, market research, marketing plan, organization, management, and management information systems. CSM use commercial marketing techniques to expand availability of contraceptive products, information and services by existing or newly created outlets, thereby complementing private and public services. While commercial and social marketing share the same management process and the same activities planned around product, price, promotion and distribution, they differ in that the goal of commerce is profit, while that of social marketing is maximizing sales and contraceptive usage. Contraceptive products supplied by USAID are described. Types of promotion used in CSMs are advertising, point-of-purchase, personal selling, and sampling: local conditions determine which is most effective. Distribution may be by commercial distributors or by program distributors if needed. The section on market research is particularly detailed and broken down into types and steps, preparing for the annual marketing plan, itself divided into 15 sub-sections. 2 methods of forecasting contraceptive demand are given, a matrix projection model and logit analysis. Types of marketing organization suggested are by functional and product specialties, the latter modeled after pharmaceutical firm management and most commonly used in CSM. Suggestions on minimal software requirements for marketing information systems, covering commodity tracking, finances, and donor agency data requirements are briefly outlined, and a monthly report form is shown.
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  10. 10

    Omnibus Study on Family Planning -- September 1988 -- report on data from males.

    Survey Research Indonesia

    Jakarta, Indonesia, Survey Research Indonesia, 1988 Sep. 40, [5] p. (SRI - 737)

    This report of a survey of awareness, usage and attitudes of 2106 men from Jakarta, Surabaya, Medan and Bandung, Indonesia, featuring condoms and the Duo Lima condom in particular, by Survey Research Indonesia, comparing 1988 to 1987, consists of 27 tables and 2 conceptual maps. Many of the data compare location or economic class. Unaided awareness of condoms had decreased from 20 to 16% overall between 1987-1988, while knowledge of vasectomy and Norplant had increased. Use of condoms as the main method fell from 7 to 5%. 10% have ever tried condoms. The main source of purchase was the Apotik (50%), drug store (195) and puskesmas (12%). The most common condom pack size purchased was 12, followed by 3 and 6. Men described condoms' "messiness" as their worst drawback. Most users tried condoms for <1 year, indicating falling off of use. Awareness of the Duo Lima brand has increased to 48%, up from 43% in 1987. It was the 1st brand mentioned by all men; 69% recalled Duo Lima advertising, primarily on radio, on billboards, and in newspapers. Duo Lima was the leading brand with 39% of subjects using it. Perceptual maps placed Duo Lima as an attractive, modestly priced, well advertised brand, the right size, and best suited for family planning.
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  11. 11

    Private sector local production of contraceptives: current options for A.I.D.

    Program for Appropriate Technology in Health [PATH]

    Seattle, Washington, PATH, 1990 Apr. v, 80, [30] p.

    A private contractor for the US Agency for International Development did a study on the provision of assistance to the private sector in developing nations for the production of contraceptives. The study has 4 objectives; to provide USAID with various strategies for meeting the demands for contraceptives in developing countries in the 1990's; to recommend activities to facilitate local private production of contraceptives; to provide an update on certain examples in the production of contraceptives in Egypt, Bangladesh, India, and Mexico; and to outline how developing countries can gain technical assistance for private sector production from US private and government agencies. Results indicate that estimated capital investments required for local production are modest. There are large scale projects in Egypt, India, and Bangladesh to initiate large scale local production of contraceptives. Most of the capital investment and operating costs can be paid in local currency. However, in countries other than Bangladesh and Egypt, there are limited opportunities for USAID to assist in the establishment of new private sector production ventures, but there are possibilities for upgrading and expanding existing facilities. Technical services provided by government and private agencies can assist developing country firms with local production of contraceptives. It was recommended that assistance be provided to initiate, upgrade, and expand local contraceptive production in selected developing countries. The transition from imported donor supplied to local production should be facilitated as well as intermediate production. Long term investment by technology suppliers should be ensured. Public-private partnerships should be included and supported. USAID should provide assistance in quality oversight capabilities, establish a clearinghouse for requests, and coordinate with other agencies. Case studies on contraceptive production in India, Bangladesh, Egypt and Mexico are presented.
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  12. 12

    Physicians, patients clamor for IUDs.

    MEDICAL WORLD NEWS. 1986 Sep 8; 27(17):98-9.

    In January 1986, G.D. Searle announced its decision to pull its IUDs from the US market, requesting physicians to voluntarily return any remaining IUDs. US physicians returned more than 100,000 of Searle's products, but some have declined to comply with the request and are continuing to use the IUDs they have on hand. Additionally, a growing number of American women are traveling to Canada to be fitted with Searle's products. Alza Corporation announced on July 25 that it will continue marketing its hormone-releasing unit, Progestasert, in the US. Since January, Alza has been limiting the availability of its IUDs to physicians who had placed orders for the product during the previous 2 years, but the company has experienced a marked increase in demand for Progestasert from American doctors since its July announcement. Prior to Searle's January 31 discontinuation of its IUD business in the US, some obstetricians/gynecologists, anticipating the Searle move, placed large orders for the Cu-7 and Tatum-T to meet their patients' needs for at least several months. Other doctors purchased the devices from colleagues who otherwise intended to comply with Searle's request to return them. Searle's decision was preceded by Ortho Pharmaceutical Corporation's decision last September to stop selling its Lippes loop IUD, and some American physicians have stopped inserting IUDs due to the litigious climate. As part of its decision to remain in the IUD market, Alza has revamped its product labeling and now provides 2 package inserts -- 1 for the physician and 1 for the patient. Jacqueline Darroch Forrest, research director of the Alan Guttmacher Institute in New York, contends that if current IUD users switch to other methods in the same proportions as women have in the past, they can expect unintended pregnancy rates 3 times greater, on average, than the IUD's 4% failure rate. Planned Parenthood hopes an entrepreneurial group will bring to the US market the T-380A, an FDA-approved IUD developed by the Population Council. Now being distributed in several countries, the T-380A is said to be more effective than even the Copper-7 or the Copper-T. Although Searle has won 9 of 11 lawsuits involving its IUDs, most companies regard the American market as too risky. Alza has faced few liability problems. Over the 10 years that Progestasert has been on the market, Alza and its product liability insurers have paid out less than $250,000 in claims against all of its products combined.
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  13. 13

    Mechanical contraceptives--intra-uterine devices.

    International Organization for Standardization [ISO]

    [Stockholm, Sweden], ISO, 1981. 4 p. (Technical Report 7439; Ref. No. ISO/TR 7439-1981 (E))

    This Technical Report, 7439, was drawn up by the Technical Committee ISO/TC 157, "Mechanical Contraceptives," and approved by ISO/TC 157 at a meeting in Chicago during May 1978. It was published in the form of a Technical Report rather than an International Standard because of the lack of an objective means of assessing IUDs. IUDs present certain unique problems for standardization. In the case of IUDs, the very wide variety of shapes, sizes, and other properties allow only a general description of its features. Thus, the physical dimensions and characteristics can only be standardized to a limited extent. This Technical Report describes basic requirements for IUDs, associated insertion instruments, and for packaging, labeling, and storage of such devices. The more important performance criteria must be assessed by clinical experience and consequently remain outside the scope of this Technical Report. The IUD, which may or may not have a tail or thread, is intended to be placed and left entirely in the uterine cavity except for any tail or thread which may extend through the cervical canal into the vagina. The manufacturer shall supply to the responsible national authorities detailed specifications and drawings of the product and whatever information is requested. In general, an IUD shall be designed to permit easy insertion into the uterus, resistance to expulsion from the uterine cavity, and easy removal from the uterus. When inserted according to the manufacturer's instructions, which shall be clearly given, the device shall produce an acceptable level of efficacy and minimal incidence of adverse reactions. The dimensions and tolerances shall be consistent with the currently licensed article. The materials of which the IUD, including any tail or thread, and the insertion instrument are made shall be sufficiently resistant to unintended influence by the body fluids and tissues and must be biologically compatible. The sterilization procedure shall not have significant detrimental effect on the properties of the material. All tests shall be carried out on the final product prior to distribution for use. The sterile IUD shall be individually packaged with its insertion instrument.
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  14. 14

    International standardization of contraceptives. Memorandum ISO/TC 157.

    International Organization for Standardization [ISO]

    [Unpublished] 1981 Mar 5. 6 p.

    The International Organization for Standardization (ISO) at present comprises the national standards bodies of 87 countries. Its objective is to promote the development of standards in the world with a view toward facilitating international exchange of goods and services and developing mutual cooperation in the sphere of intellectual, scientific, technological, and economic activity. The results of ISO technical work are published as International Standards. Technical Committees (TCs) are created by Council for clearly defined fields of activity. The Swedish International Development Authority (SIDA) proposed in 1972 to the Swedish member of ISO (SIS) that it set up an ISO/TC on condoms. The reasons for this request were the experiences SIDA has had when buying condoms for developing countries. In 1974 a TC, designated ISO/TC 157, was created to deal with standardizations of mechanical contraceptives. The 1st meeting of ISO/TC 157 was held in Stockholm in February 1975. At that meeting it was decided to give priority to condoms but to also deal with IUDs and vaginal barriers. Since the 1st meeting the TC has also met in New Delhi in November 1976, in Chicago in May 1978, and in Colombo in February 1981. As a result of the work, International Standards have been published for rubber condoms. The standards cover the following: determination of length; determination of width; determination of color fastness; testing for holes; determination of bursting volume and pressure; determination of tensile properties; packaging and labeling; and storage. A technical report on IUDs has been agreed upon and will be published in the near future. The TC has also agreed on additional test methods for condoms and has carried out some work on limit requirements on condoms based upon approved test methods. The TC has begun to discuss the problems related to certifications of condoms. The work that the ISO/TC 157 has carried out thus far will most likely result in simplified purchase and inspection procedures for condom consignments all over the world. All International Standards must be reviewed at not more than 5 year intervals.
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  15. 15

    Local production of contraceptives in developing countries.

    Free MJ; Genstein JM; Morrow MM; Perkin GW

    Seattle, Washington, Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), 1982 May. 43 p.

    The local production of contraceptives is considered in this paper. Focus is on the following: perceptions of contraceptive supply and production issues (international and local viewpoints); the decision making practice (the limits of production, purpose and nature of feasibility studies, options for implementation, special problems and considerations in assessing feasibility of industrial projects in developing countries, specific product considerations, and quality control); current status (existing facilities, models for local production of contraceptives, and project and production costs); and strategies (donors and the developing countries). In the face of increasing uncertainty regarding the nature and extent of donor assistance, many governments are exploring in greater detail the options available to them for self-support in family planning. Except for those countries that already have a substantial contraceptive manufacturing industry, the options for self-support in contraceptive supplies involve either procurement using international currencies or development of the means to manufacture locally. Very few developing countries presently have use rates sufficient to justify full-scale local production, but packaging and testing operations may be scaled to the needs of many countries. Feasibility studies are necessary for developing country governments to make a decision whether to participate directly or through the private sector in the manufacturing of contraceptives. The donor agencies can play a vital role in these decisions. From the local perspective, several benefits arise from local production of contraceptives, providing contraceptive use is sufficient to justify a reasonable scale of production technology. Full-scale production of contraceptives can only be carried out efficiently at production volumes above a minimum scale of operation. The technologies associated with different contraceptive products are sufficiently different that each presents a unique set of problems and calls for special consideration at a very early stage of the study. Condom, IUD, and oral contraceptive production are reviewed. The current cost of setting up complete contraceptive production capabilities at the minimum economic scale in a developing country is likely to be in the range of U.S. $5-8 million for condom production, $4-6 million for oral contraceptive formulation and tabletting, and $2-3 million for sterilized, individually packaged, long-life copper IUD production.
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  16. 16

    Instructions for immediate postpartum insertion of either the Delta-Loop or Delta-T IUDs with either uterine, ovum or ring forceps.

    International Fertility Research Program [IFRP]

    [Unpublished] 1981 Jul. 2 p.

    Detailed instructions for immediate postpartum insertion of the Delta Loop or Delta T IUDs with either uterine, ovum, or ring forceps are presented. The steps are as follows: 1) put on a clean and sterile glove; 2) expose the postpartum cervix by using a posterior vaginal retractor and a right-angled or vaginal wall retractor; 3) grasp the anterior lip of the postpartum cervix at the 12 o'clock position with a ring forceps; 4) thoroughly clense the vagina and the cervix with an antiseptic; 5) open the sterile IUD pack and with a 2nd sterile ovum or ring forcep grasp the IUD as is shown in figures accompanying these instructions, and as the IUD is clamped in the forceps for insertion, slip the distal portion of the string between the ring finger and small fingers to keep the strings straight; 6) with the left hand, apply gentle downward traction on the anterior lip of the cervix via the ring forceps and simultaneously begin to insert the Delta IUD through the cervical canal; 7) resistance is felt as the IUD reaches the fundus, and at this point the left hand should be placed on the abdomen and the fundus palpated; 8) release the ring forceps holding the IUD once the IUD has reached the fundus, separating the blades and gently withdrawing the forceps from the uterine cavity; 9) release the ring forceps that have been grasping the cervix following removal of the ring forceps that held the IUD; and 10) trim the strings 1.5 cm from the cervical os. The patient should be educated not to pull on the IUD strings if they begin to protrude within the next 7-10 days. She should be instructed to return to have them shortened. The patient should also be advised to examine sanitary napkins for the IUD in case it is expelled up to the time of her 1st follow-up visit. At follow-up, if the strings of the IUD are visible, the physician should straighten them to remove any excess thread from the uterus. Cut the strings 1.5 cm from the cervical os. On each successive visit, the length of the strings should be determined. If the strings are not visible, it can be determined that the IUD is in place simply by sounding the uterus and sensing the presence of the IUD.
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  17. 17

    Statement on intrauterine devices.

    International Planned Parenthood Federation [IPPF]

    IPPF Medical Bulletin. 1981 Dec; 15(6):1-3.

    These policy statements and guidelines from the International Planned Parenthood Federation's (IPPF) International Medical Advisory Panel (IMAP) concern IUDs. The following contraindications to IUD use are recognized: 1) pelvic inflaminatory disease, 2) known or suspected pregnancy, 3) history of previous ectopic pregnancy, 4) gynecological bleeding disorders, 5) suspected malignancy of the genital tract, 6) congenital uterine abnormalities or fibroids distorting the cavity, and 7) anemia, blood coagulation, severe cervical stenosis, copper allergy, Wilson's disease, and others. Generalities regarding appropriate IUDs are: 1) non-medicated devices (e.g. Lippes Loop) are studied for women who may not return for regular check-ups, 2) smaller medicated devices usually cause less menstrual blood loss than the non-medicated devices, 3) smaller devices are better for a smaller uterus and larger devices for the larger uterus, and 4) when a smaller device is expelled it is advisable to try a larger one and vice versa. Dalkon Shields should not be used by the IPPF system and all women using them should have the device removed. Correct insertion of IUDs is important and should be done by properly trained personnel. The timing of insertion is best during the menstrual period. Withdrawal of the applicator while leaving the device in place is the recommended insertion technique. Sterilization of IUDs should follow instructions on bulk-packaged IUDs. Complications include perforation, bleeding and pain, infection, and ectopic pregnancy. IUD removal should be done during menstruation. Good clinical management and follow-up care are recommended.
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  18. 18

    Intrauterine contraception information for the patient.

    Benson H; Place V

    DRUG INFORMATION JOURNAL. 1978 Jan-Mar; 12(1):65-9.

    To determine what a patient package insert (PPI) for an intrauterine contraceptive should contain, a survey was conducted using a group of 348 women randomly selected from the clinical population of 3 researchers in the Progestasert system trials in Palo Alto and San Jose, California and in New York City. The women were randomly assigned into 2 groups: A (175 women) and B (173 women). Demographic characteristics of both groups were similar (90% Caucasian; 21-37 years of age and with at least some college education). Questionnaires were mailed and $5 was offered for returned questionnaires. Group A received a PPI similar to that proposed in The Federal Register of 7/1/75 while group B received a PPI prepared by ALZA. In data analysis, statistics were used in a descriptive rather than mathematical sense. Of the 301 questionnaires mailed, 256 or 85% responded (134 in group A and 122 in group B). 95% and 98% in groups A and B, respectively, agreed that brochures are important sources of information (Table 1); 98 and 100% agreed that all system users should receive the PPI. Both groups were unanimous also, in agreeing that brochures should be read prior to insertion of device. Readers of the company-prepared brochure found its informational content more complete than the FDA-prepared version. The findings suggest that brochures should contain information on how the contraceptive works; who may use it; how it is used; its appearance; potential adverse effects; and other pertinent information.
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  19. 19

    IUD reference chart for program planners.

    Piact Product Newsletter. 1979; Third Quarter:1-8.

    A chart format is used to present information on the packaging, pricing and availability of the major IUDs currently in use. The IUDs selected for inclusion are the devices commonly in use internationally, commercially available, and/or those for which substantial clinical data exists. In some instances, recent modifications to standard devices have been included. A list of donor agencies follows the IUD chart. Prices are quoted in 1979 United States dollars, unless otherwise indicated. 2 kinds of public sector prices are available to nonprofit programs -- volume purchases of individually packaged devices and a price for devices which are packaged in bulk only.
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  20. 20

    Contraceptives and common sense: conventional methods reconsidered.

    Bruce J; Schearer SB

    New York, Population Council, 1979. 125 p.

    Barrier or conventional methods of contraception--those which physically block the passage of sperm into the uterus or chemically inactivate the sperm in the vagina--are an important group of methods which have been too long ignored. A large and sustained effort to develop new and better barrier contraceptives is sensible and necessary. The effectiveness of the barrier methods is reviewed, including the condom, diaphragm, and vaginal spermicides. Also considered is current acceptability and emerging demand for barrier contraceptives; groups for whom barrier methods have special appeal (adolescents, women over 30, men); using science and technology to improve barrier methods; and the status of current research efforts. The apparent lack of popularity of barrier methods in developing countries is examined, and it is felt that whether these methods can be effective, acceptable contraceptives for a large number of couples in such countries is unknown because the methods have been virtually untried. Recommendations for policy and action are directed at providing supportive family planning services; special programs for adolescents; improvements in packaging and labeling; increasing applied and basic research; and pilot tests in developing countries.
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  21. 21

    (Brochure regarding use of IUDs.)

    United States. Department of Health, Education, and Welfare

    (Press release. Contact: Shaffer, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20852) November 4, 1977. 2 p.

    An FDA (Food and Drug Administration) ruling required that a special brochure describing uses and risks associated with IUDs be given to women before physicians could insert IUDs. A similar ruling involving birth control pills and steroidal preparations was enforced in 1970 and 1977. FDA Commissioner Donald Kennedy stated that it was the FDA's objective to provide information regarding the advantages and disadvantages of contraceptive methods to facilitate the decision-making process of couples. The brochures described the IUD; its effectiveness; things a woman should know and discuss with her doctor before IUD insertions; how to check to see if the IUD is still in place, what to do if it is not; possible side effects and adverse effects to be reported to doctors; and, what to do in case of pregnancy with the IUD still in place. The regulation also provided for uniform professional labeling for IUDs. Required information directed to physicians included instructions for IUD insertions, indications for IUD removal, possible complications, and when IUD should be replaced or not used at all. The ruling took effect November 7, 1977.
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  22. 22

    On IUD package inserts. (Letter to the editor)


    American Journal of Public Health. March 1978; 68(3):269.

    Dr. Harriet Benson and her colleagues of the ALZA Corporation are congratulated for their article, "Patient Education and IUD Contraception: A Study of 2 Package Inserts." By comparing patient responses to 2 proposed package inserts from the Food and Drug Administration (FDA) and ALZA, they made an important contribution to documenting the educational value of patient-oriented information. Their findings indicated that any educational brochure was preferable to none, that illustrations were helpful to the patient's comprehension, and that addressing the possible risks associated with IUD use did not dissuade women from choosing the IUD. Benson, however, overlooked the following disturbing statistically significant differences between the FDA and ALZA group: 1) the ALZA brochure was felt to be more commercial in approach; 2) the women reading the FDA insert were more likely to feel that it provided a clearer discussion of the potential danger of IUD use than those reading the ALZA brochure; and 3) a detailed reading of both brochures contained no discussion of any other types of IUDs. More importantly, 16% of ALZA respondents were unaware that the IUD should be removed if pregnancy occurs with the device in situ. Futhermore, ALZA policy is to defer to "medical judgment" in this situation, although the data are clear; any IUD should be removed as soon as the pregnancy is diagnosed. While these inserts have already been helpful to women choosing oral contraceptives, they should be of similar value to women opting for IUDs. The author maintains, however, that such information should state risks and alternatives in a non-promotional non-judgmental manner.
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  23. 23

    Options for intrauterine device production in developing countries: a resource document.

    Free MJ

    Seattle, Washington, Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), 1982 Feb. 72 p.

    This document provides a source of early planning information to private or public groups considering local production of IUDs in developing nations. A general assumption is made that the IUD of interest will be an "active" device and most likely one of the new generation of copper-bearing plastic IUDs. This assumption is made because these IUDs are more generally available for licensed technology transfer and have been developed in a variety of configurations, by noncommercial as well as commercial groups. The following areas are covered: IUD manufacture operations (manufacture of plastic parts, application of copper components, suture tying, assembling and packing, sterilization, and quality control); early decisions (the selection of a technology, making or buying components, subcontracted operations, raw material substitutions, skill requirements, and space requirements and facilities); notes on specific manufacturing procedures (injection molding, applying copper to the plastic frame, sterilization with ethylene oxide, good manufacturing practices for quality control of IUD production, and technology for steroid releasing IUDs); and special considerations for developing countries (sources of technical assistance and useful books and documents). The IUD production operation can be organized totally as an assembly operation or can involve the production of 1 or more components. An overview of these options is included.
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  24. 24

    International standardization of mechanical contraceptives.

    Mellstam S

    IPPF Medical Bulletin. 1983 Jun; 17(3):2-4.

    At least 12 countries have regulations for condoms, and because of the complicated regulations relating to condoms the International Organization for Standardization (ISO) was asked to create a committee for contraceptives. Its objective is to promote the development of standards throughout the world to help the international exchange of goods and services. Following discussions between the World Health Organization (WHO) and ISO it was decided in 1974 to establish a technical ISO committee that would deal with international standards for mechanical contraceptives, comprising condoms, diaphragms, and IUDs. It was also decided that spermicides and oral contraceptives (OCs) should be excluded from the ISO effort, but that they should fall within the responsibility of WHO. The committee, entitled ISO/TC 157 Mechanical Contraceptives, was represented by 35 member countries in 1982. The object of standardizing condoms is to obtain a satisfactory quality that can be accepted throughout the world. To achieve that purpose, acceptable test methods and associated limit requirements and values must be determined, along with rules for storage, packaging, and labeling. The most important factors in determining condom quality are the need to reach agreement on an acceptable number of holes in the condom and the ability to establish limit values for the mechanical properties of the condom. Specific requirements regarding dimensions, resistance to storage, packaging, labeling, and appropriate storage are also important. Up to 1982 the work of ISO for condoms resulted in 8 published international standards, of which 6 deal with test methods, 1 with packaging and labeling, and 1 with storage. Agreement has also been reached within the ISO committee on an additional 3 draft standards. Due to the comparatively small use of diaphragms, standardization efforts in this area do not have the highest priority. ISO/TC 157 has formulated 10 drafts which are being prepared for distribution to the ISO member countries for purposes of voting. 7 of these standards deal with test methods, 1 with sampling and requirements, 1 makes storage recommendations, and 1 refers to packaging and labeling. A working group for standardizing IUDs was established in 1976. It was agreed within ISO/TC 157 after almost 3 years to publish a Technical Report (TR 7439) for IUDs. The report deals with such things as the definition of IUDs, general requirements for type approval, batch inspection, storage recommendations, and packaging and labeling. The report shall constitute the basis for continued standardization efforts for IUDs.
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  25. 25

    Intra-uterine devices--Part 3: packaging and labelling.

    International Organization for Standardization [ISO]

    [Stockholm], ISO, 1982. 4 p. (Draft International Standard ISO/DIS 7857/3)

    This part of the Draft International Standard specifies requirements for the packaging and labeling of IUDs. The devices may be packaged either individually or in multiple packages containing up to 100 IUDs and an appropriate number of insertion instruments. The individual package should ensure maintenance of the sterility of the contents under dry, clean, and adequately ventilated conditions of storage; a minimum risk of contamination of the contents during removal from the package; and that when opened, the package cannot be easily resealed. The contents of the unopened multiple package must be sterile. A convenient number of individual or multiple packages shall be packaged in 1 or more outer containers sufficiently robust to protect the contents during transit and storage. Each individual package shall be labeled with the following information: brandname of the IUD, manufacturer's name and address, IUD size (if appropriate), batch number, expiration date (if required), month and year of sterilization, and the wording "Warning--sterile unless package is damaged or opened. Insertion instrument should not be reused and should be destroyed after use." Multiple packages should list the 1st 6 of these items and also disinfection instructions; outer containers should additionally include storage directions. Directions for use of the IUD should accompany each package and include the following: insertion directions, details of contraindications and adverse reactions as well as precautions and warnings (as required by the licensee body), other information required by the licensee body, and the recommended method of disinfection if appropriate.
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