Contraception
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![]() Putting the man in contraceptive
mandate
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Yeast Infection ![]() Putting the man in contraceptive
mandate Announced on January 20, 2012, and made effective August 1, 2012, the contraceptive mandate is an extension of the Patient Protection and Affordable Care Act (ACA) that sanctioned the provision of contraceptives and sterilization services to women at no cost. While the mandate is a landmark for women's health care, it has not yet directly addressed a role for men. Male involvement is often either absent or a late addition to reproductive policies, as seen with past developments in sexual health such as emergency contraception,1 the human papillomavirus vaccine2 and expedited partner therapy for sexually transmitted infections.3 As written currently, the ACA does not direct insurance carriers to reimburse for vasectomy nor prospective male contraceptives or counseling.4 Sterilization rates in the USA have remained fairly constant over the last 40 years. The National Survey of Family Growth (20062010) reported that 27% of women rely on female sterilization for birth control; only 10% rely on their partners' vasectomies.5, 6 The exclusion of coverage for vasectomy may widen this disparity by comparatively increasing cost barriers and decreasing social expectations for men. In comparison to female sterilization methods, vasectomy has benefits with respect to efficacy, cost and safety;7 the ACA's exclusion of vasectomy is neither ethical nor evidence based and warrants re-examination. Based on the data from the US Collaborative Review of Sterilization, the cumulative probability of failure for female sterilization at 5 years postprocedure was 13.1/1000 procedures (95% confidence interval: 10.815.4), compared to vasectomy at 11.3 (2.3, 20.3).8, 9 Other sources cite higher annual failure rates for tubal ligation, 0.130.17%, compared to vasectomy at 0.010.04%.10, 11 Female sterilization also carries greater risk of complication than does vasectomy. Abdominal access for tubal ligation carries 20 times the risk of major complications compared to vasectomy, which is performed in the office under local anesthesia ideally with a single <10-mm scrotal incision.12 Postoperative complications, such as bleeding and infection, are also more common among tubal ligations than vasectomies (1.2% vs. 0.043%).13 Costs of these complications each year are also estimated to be US$ 62.52 vs. US$ 0.06 for tubal ligation and vasectomy per procedure, respectively. Pregnancy complications related to sterilization failure are also more common and costly for tubal ligation. A failed vasectomy leads to intrauterine pregnancy that can be terminated for US$ 40314 or carried to term and delivered for US$ 9318.15 Alternatively, failed tubal ligation carries a 33% risk of ectopic pregnancy, with significant risk of morbidity and mortality,16 costs quoted at US$ 10,613.17 In addition to being more effective and safer than female sterilization methods, vasectomy is less expensive. A 2012 cost index cites the average cost of vasectomy as approximately US$ 708, compared to the average cost of tubal ligation methods at US$ 2912.18 Tubal ligations performed in the operating room incur anesthesia fees, leading to procedures costing up to US$ 3449. Even office-based transcervical methods, US$ 1374, are still more expensive than vasectomy.19 Despite the comparatively low cost of vasectomy, a quarter of insurance carriers do not cover the procedure.20 Even if insurers paid for 70% of the procedure, the cost to the patient would still be significant (e.g., a 30% patient portion of the US$ 708 vasectomy fee is US$ 212).18 Men with insurance may not even see any benefit as they may still be responsible for the full cost of their deductibles, which, at an average of US$ 1097, is already greater than the cost of a vasectomy.21 Some insurance carriers may independently elect to provide vasectomies without cost sharing; however, a national policy mandating coverage of this highly effective and cost-effective procedure would aid efforts to increase widespread uptake. Even the least costly, most commonly performed and effective method of female sterilization, postpartum partial salpingectomy, can only be performed within 48h of delivery. Furthermore, only half of women desiring the procedure ultimately receive it.22, 23 Considered an elective procedure, postpartum tubal ligations are subject to routine delays on labor and delivery, as well as the religious affiliations at approximately 12% of hospitals that prohibit provision.24 Regret may also be more common in the postpartum rather than interval setting,25 especially for low-income, minority women who may feel pressured to accept their only perceived opportunity for a Medicaid-funded sterilization.26 As patients may not seek sterilization outside the postpartum context or receive less effective procedures at a later date, the availability of no-cost vasectomy is especially important.27 Though health care providers should prioritize the care of women, the lack of male involvement in reproductive health care contributes to the excessive burdens of reproduction and contraception that these women experience. Without guaranteed reimbursement for the care of male patients, reproductive health clinics will lack the financial incentive to broaden care to include male-specific services and outreach. The marginalization of men in family planning clinics has the untoward effect of deterring men who, despite their need for help, consider these environments too embarrassing or exclusive to use.28 Some states already attribute rising rates of gonorrhea and chlamydia to the inability of low-resource clinics to reach men.29 Low rates of male attendance at reproductive health clinics may mislead funding sources into believing that men are not interested in these resources, when in fact more funding is needed to improve the visibility of vasectomy, train more providers and correct widespread misconceptions that prevent its uptake.30 As novel male contraceptives are currently under study, their subsidy and support from the government and pharmaceutical manufacturers depends on perceived demand as well, which may decrease due to the ACA's emphasis on the sufficiency of reproductive care for women alone.31 The US government has recognized the importance of family planning by approving the contraceptive mandate; however, its exclusion of vasectomy and provisions for prospective male contraceptives reflect the nation's current view of family planning as a woman's issue. An amendment to the contraceptive mandate would help to establish family planning as a human issue, for which the involvement of men will increase safety and overall savings, as well as ethically balance the weight of the reproductive burden. Call to action The Health Resources and Services Administration of the US Department of Health and Human Services (DHHS) recognizes the unique health needs of women and extended their health care coverage under the ACA to include several preventive services, including the provision of contraceptive counseling, contraceptive methods and sterilization. However, the current federal interpretation of this legislation excludes family planning services for men despite the fact that women benefit from male reproductive awareness and use of contraceptives. There are still multiple avenues for change: 1. The DHHS can directly amend the ACA's contraceptive mandate to specifically include cost-free coverage of male contraceptives, sterilization and counseling. The National Health Law Program, a public interest law firm serving underserved and underinsured Americans, has already begun asking the DHHS to extend critical reproductive services to men. Their efforts will be bolstered by the written contribution of physicians and health care providers to state and federal representatives. Government representatives may otherwise be unaware of the efficacy, safety and cost savings of vasectomy compared to tubal ligation, as well as the patient experiences of health care inequality that provide the emotional impact needed to invoke change. Petitions can further help representatives understand the demand for gender equality in reproductive decision making. Awareness campaigns and social media need to be used to inform more people about the significant benefits of male contraception and sterilization, as well as their underuse compared to female methods. Support of more research on male methods, their safety and their impact on reproductive health outcomes will better inform clinical practice recommendations that will impact future amendments to the ACA. References 1. EC: questions and answers . US Food and Drug Administration. 14 Dec 2006. Accessed 18 Jan 2013 2. Burgess S. FDA approves new indication for gardasil to prevent genital warts in men and boys. FDA News Release.Accessed 18 Jan 2013. 3. Legal Status of Expedited Partner Therapy (EPT) . Sexually Transmitted Diseases. Centers for Disease Control and Prevention, 24/7: Saving Lives, Protecting People. Website. Accessed 18 Jan 2013 4. Department of Health and Human Services. Coverage of certain preventive services under the Affordable Care Act. Federal Register, Proposed Rules. 6 Feb 2013; 78(25): 8456-8458. 5. NCHS Fact Sheet, National Survey of Family Growth. Centers for Disease Control and Prevention, 24/7: Saving Lives, Protecting People. 6. Jones J, Mosher W, Daniels K, et al. Current contraception use in the United States 20062010, and changes in patterns of use since 1995. National Health Statistics Reports. 18 Oct 2012; 60. 7. Shih G, Turok DK, Parker WJ. Vasectomy: the other (better) form of sterilization. Contraception. 2011;83:310315 8. Peterson HB, Xia Z, Huges JM, et al. The risk of pregnancy after tubal sterilization: findings from the US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174(4):11611168 9. Jamieson DJ, Costello C, Trussell J, et al. The risk of pregnancy after vasectomy. Obstet Gynecol. 2004;103(5 Pt 1):848850 10. Trussell J, Leveque JA, Koenig JD, et al. The economic value of contraception: a comparison of 15 methods. Am J Public Health. 1995;85(4): 11. Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive technology (20th revised edition). New York: Ardent Media; 2011; 12. Adams CE, Wald M. Risks and complications of vasectomy. Urol Clin N Am. Aug 2009;36(3):331336 13. Trussell J, Leveque JA, Koenig JD, et al. The economic value of contraception: a comparison of 15 methods. Am J Public Health. 1995;85:494503 14. Dilation and Curettage . Healthcare Blue Book. Website. Accessed 24 Jun 2013. 15. March of Dimes . The healthcare costs of having a baby. Website. Accessed June 2008 16. Peterson HB, Xia JM, Huges JS, et al. The risk of ectopic pregnancy after tubal sterilization. N Engl J Med. 1997;336:762767 17. Agency for Healthcare Research and Quality . Healthcare Cost and Utilization Project (HCUP). Website. 18. Trussell J. Update on and correction to the cost-effectiveness of contraceptives in the United States. Contraception. Jun 2012;85(6):611 19. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis.J Minim Invasive Gynecol. Jul-Aug 2005;12(4):318322 20. Kurth A, Bielinski L, Graap K, et al. Reproductive and sexual health benefits in private health insurance plans in Washington State. Fam Plan Perspect. 2001;33(4): 21. Rae M, Panchal N, Claxton G. Snapshots: The Prevalence and Cost of Deductibles in Employer Sponsored Insurance. The Henry J Kaiser Family Foundation. Website. Written Nov 2012. Accessed Sep 2013 22. Boardman LA, Desimone M, Allen RH. Barriers to completion of desired postpartum sterilization. R I Med J. 2013;96(2):3234 23. Zite N, Wuellner S, Gilliam M. Failure to obtain desired postpartum sterilization: risk and predictors. Obstet Gynecol. April 2005;105(4):794799 24. The facts about Catholic healthcare . Catholics for a free choice. Sep 2005. Accessed 11 July 2013. 25. Wilcox LS, ZXeger SL, Chu SY, et al. Risk factors for regret after tubal sterilization: 5 years of follow-up in a prospective study. Fertil Steril. 1991;55:927933 26. Hillis SD, Marchbanks PA, Tylor LR, et al. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gyne 27. Access to postpartum sterilization . Committee Opinion No. 530. American College of Obstetricians and Gynecologists.Obstet Gynecol. 2012;120:212215 28. Lindberg C, Lewis-Spruill C, Crownover R. Barriers to sexual and reproductive health care: urban male adolescents speak out. Issues Compr Pediatr Nurs. 2006;29(2):7388 29. Dailard C. Family Planning Clinics And STD Services. The Guttmacher Report on Public Policy. Aug 2002; 5(3). Accessed 30 Jun 2013 30. Shih G, Dube K, Sheinbein M, et al. He's a real man: a qualitative study of the social context of couples' vasectomy decisions among a racially diverse population. Am J Mens Health. May 2013;7(3):206213 31. Dorman E, Bishai D. Demand for male contraception. Expert Rev Pharmacoecon Outcomes Res. 2012;12(5):605613 Source: Brian T. Nguyen Grace Shih David
K. Turok, www.arhp.org/publications-and-resources/contraception-journal/january-2023
There are a number of contraceptive choices which may change throughout your life. To decide which method to use now, consider how well each one will work for you:
Here is some information to help you decide... Women & Men: This means no sex play. This will keep sperm from joining the egg. Effectiveness
Advantages
Possible Problems
Cost
Women & Men: This is sex play without vaginal, anal or oral intercourse. This will keep sperm from joining the egg. Effectiveness
Advantages
Possible Problems
Cost None Women & Men: An operation to keep sperm from joining the egg.
Effectiveness
Advantages
Possible Problems
Tubal sterilization:
Vasectomy:
Cost
Women: A clinician will put six small capsules under the skin of a woman's upper arm. Capsules constantly release small amounts of hormone that:
Removal can be done at any time but must be done by a clinician. Effectiveness
Advantages
Possible Problems
Cost
Women: Your clinician will give you a hormone shot in your arm or buttock every 12 weeks to:
Effectiveness
Advantages
Possible Problems
Cost
Women: Your clinician will put a small plastic device in the woman's uterus. The IUD contains copper or hormones that:
Effectiveness
Advantages
Cost $150-$300 for exam, insertion, and follow-up visit. Some
family planning clinics charge according to income. Women: The clinician will prescribe the right pill. Take one pill once a day. Complete one pill-pack every month. Combination pills contain estrogen and progestin. Mini-pills contain only progestin. Pills contain hormones that work in different ways.
Effectiveness
Advantages
Cost
The Condom Women & Men: Covering the penis with a sheath before intercourse to keep sperm from joining egg.
Effectiveness
Increase your protection:
Advantages
Possible Problems
Cost
Nearly fulfilling the persistent dream that is consequences-free sex, the FDA has approved a contraceptive vaginal ring that is 99% effective. Called Nuva Ring, it's better than playing with the 95% effectiveness of the Pill and 97% of condoms. FHM, 5/02 The only thing that the NuvaRing has in common with the diaphragm is that it sits in the vagina. They are not remotely similar forms of birth control.
Here is a site regarding the disaphragm: www.fwhc.org/birth-control/diaphram.htm
Women & Men: When the man pulls his penis out of the vagina before he "comes" to keep sperm from joining the egg. Effectiveness
Advantages
Possible Problems
Cost
Women: The clinician will fit you with a shallow latex cup (diaphragm) or a thimble-shaped latex cap (cervical cap). Clinician also will show you how to coat diaphragm or cap with Spermicide and put it in your vagina to keep sperm from joining the egg Effectiveness
Advantages
Possible Problems
Diaphragm:
Cervical Cap:
Cost
Women:
Effectiveness
Advantages
Possible Problems
Cost
Women: A professional will teach you how to chart your menstrual cycle and to detect certain physical signs to help you predict "unsafe" days. Abstain from intercourse (periodic abstinence) or use condoms, diaphragm, cervical cap, or Spermicide (FAMs) during 9 or more "unsafe" days. Includes:
Effectiveness
Advantages
Possible Problems
Cost
Women: Effectiveness Advantages Possible Problems Cost Non-hormonal Contraceptive Methods
QRG Some women prefer contraceptive options that do not contain hormones. To avoid hormones, these patients often choose less-reliable methods, which can contribute to the prevalence of unintended pregnancy. To help providers and patients stay up-to-date on the
most effective ways to prevent pregnancy with non-hormonal
contraception, ARHP has updated our popular Non-hormonal
Contraceptive Methods Quick Reference Guide
The QRG series is one of ARHPs most popular
resources, offering providers distilled, evidence-based
information in an easily-accessible format. Download the
latest in the series on Non-hormonal
Contraceptive Methods You May Want Emergency
Contraception Women:
Emergency Contraception ...is designed to prevent pregnancy after unprotected
vaginal intercourse.
Don't use emergency hormonal contraception if you:
Consult your clinician about taking emergency hormonal contraception if you are:
Source: www.plannedparenthood.org/bc/CONTRACHOICES.HTM
Sarah
Wrap - A Warning Oral Contraceptive Increases HIV
Risk Using hormonal contraception, such as the Pill or injections like Depo-Provera, may increase a woman's risk of acquiring HIV and transmitting it to her partner. The Pill and other hormonal methods of contraception are associated with an increased risk of HIV for both men and women, researchers are reporting. An observational analysis from a randomized trial of couples in which one partner had HIV and the other did not found that HIV-negative women using hormonal contraception had nearly twice the risk of catching HIV as those using other methods or none, according to Jared Baeten, MD, of the University of Washington in Seattle, and colleagues. But the study also found for the first time that HIV-negative male partners of women with the virus also face an increased risk if the women use hormonal methods of contraception, mainly injections of long-acting depot medroxyprogesterone acetate (DMPA), like Depo-Provera, Baeten and colleagues reported online in The Lancet Infectious Diseases. The study raises important public health questions and needs a randomized trial to confirm or refute the findings, the researchers concluded. One possible implication of the findings is that promotion of DMPA contraception in Africa has inadvertently fueled the HIV/AIDS pandemic a "tragic" situation, if true, according to Charles Morrison, PhD, and Kavita Nanda, MD, both of Family Health International in Durham, N.C. But curtailing the use of a very effective method of contraception could have equally tragic results, they argued in an accompanying comment article "increased maternal mortality and morbidity and more low-birth-weight babies and orphans." They also called for a randomized trial to settle what they called a "crucial public health question." The data come from the "Partners in Prevention" study, which aimed to see if treating herpes simplex II a common infection in sub-Saharan Africa might reduce the risk of acquiring HIV in couples where one partner is HIV positive and one is HIV negative. The treatment had no benefit, but Baeten and colleagues decided to examine data from the 3,790-couple trial to see if they could add anything to the debate over hormonal contraception. They found:
The researchers noted that the analysis is based on observation and may have been influenced by unmeasured confounding factors. As well, they cautioned, data on contraceptive use was based on self-report and did not include information on adherence or brand. They also cautioned that the study was not designed to
examine the contraception issue, so that only a relatively
small proportion of women used hormonal contraception and
few infections occurred among them or their partners. California Supreme Court Rules on
Contraceptive Coverage The California Supreme Court ruled on March 1st that Catholic Charities must provide its employees in California with medical coverage for birth control in spite of the organizations religious objections to contraception. California state law requires employers - except "religious employers" - to insure their workers for contraceptives if they provide coverage for other prescription drugs. The court ruled that Catholic Charities does not count as a "religious employer" because it offers a range of secular services (such as counseling, housing and immigration services) to people of all faiths without directly preaching Catholic values. Of the 20 states that mandate comprehensive coverage of
contraceptives by all health insurers that cover
prescription drugs, 12 have incorporated some form of
religious exemption. Most allow "religious employers,"
variously defined, to opt out where the coverage would
conflict with the employer's bona fide religious tenets. Male Hormonal Contraceptive
For U.S. Market Pharmaceutical companies Schering AG and Organon said Thursday they aim to produce a marketable hormone contraceptive for men in five to seven years - a goal that has stumped researchers for decades. Source: www.intelihealth.com/IH/ihtIH/EMIHC000/333/333/358327.html ![]() Planned Parenthood Counseling
Patients About Voluntary Recall of the Once-a-Month
Injectable Hormonal Contraceptive Lunelle Planned Parenthood is working with Pharmacia to quickly reach out to Lunelle users, instruct them to use a barrier method like condoms, and counsel them on other contraceptive options. Continue: www.plannedparenthood.org/about/pr/021010_lunelle.html ![]() Morning After Pills Covered In California Gov. Gray Davis has ordered HMOs to pay for women's "morning-after" contraceptives, making California the first state in the nation to cover the pills. Source: www.intelihealth.com/IH/ihtIH/WSIHW000/8799/22002/347923.html ![]() A common spermicide gel -- once thought to protect against HIV -- might actually increase the risk of HIV infection. Several studies show that the ingredient nonoxynol-9 -- when used frequently in anal sex -- apparently can cause lesions that increase the body's exposure to HIV. It's an issue that more than 85 health organizations and public health researchers have collectively become concerned about, says Lori Heise, director of the Global Campaign for Microbicides, the group spearheading the "Call to Discontinue N-9 for Rectal Use." Forty-two percent of all condoms sold commercially in the U.S. are lubricated with N-9. In fact, N-9 has been used as a contraceptive for over 50 years, and manufacturers began adding it to condoms and lubricants in the mid-1980s when early research suggested it might offer some protection against HIV. New research has proved that to be false. "Too many consumers still have the belief that condoms with N-9 are actually offering them protection against STDs and HIV, when it may be increasing their risk when they use the condoms rectally," Heise said in a press teleconference. The problem: Even the very small amounts of N-9 on condoms "has been shown to cause sloughing of the cell lining of the rectum, which creates portals of entry for the virus, increasing risk of STD and HIV infection for people who practice rectal sex," said Heise. In fact, last fall the World Health Organization issued a strong cautionary statement against using N-9 products rectally. "They provided a clear, definitive statement that N-9 does not protect against STD and HIV transmission and should not be used for that," she added. "We're specifically asking manufacturers of sexual lubricants and contraceptives to discontinue adding N-9 to products. We're also asking retail outlets to discontinue stocking N-9 products." For every product that contains N-9, manufacturers also provide another version of that brand with lubrication that doesn't contain N-9, she pointed out. "This is extremely important for public health," said Heise. Since last June, a number of companies have agreed to take N-9 out of products, including Mayer Laboratories. Johnson & Johnson does not produce condoms in the U.S., but the company's facility in Brazil has agreed to discontinue production of N-9 condoms, says Heise. Also, a Johnson & Johnson subsidiary makes a very popular line of KY lubricants -- KY-Plus -- that contain N-9. In July, Johnson & Johnson took action to stop production. However, three of the largest condom manufacturers -- including the maker of Trojan brand condoms --have no plans to remove N-9 from their products, she added. "Condoms are still the best way that sexually active individuals can prevent disease and pregnancy," says Vanessa Cullins, medical director of Planned Parenthood. "It's so important that the public understands that condoms are still the best protection against pregnancy and STDs. The issue is not condoms, it's N-9." Should people throw out those at home -- or still use them -- if they do not practice anal intercourse? "People do not need to throw away their N-9 condoms as long as they are low-risk and as long as they are utilizing those condoms for pregnancy prevention," says Cullins. "However, if that person is using them during anal intercourse -- or has sex multiple times during the day, or bought them to prevent STDs -- they should not use the N-9 condoms they have stored," Cullins adds. "That specific individual is at risk of increased transmission of disease." In fact, the small amount of N-9 on a condom is insufficient as a contraceptive, says Heise. "It gets rubbed off as the condom enters the woman. There's a higher dosage in the type used with diaphragms, and you're putting it right against the cervix." The FDA regulates both condoms and lubricants, and it is in FDA jurisdiction to remove the products from the market if necessary. "But as we know, the FDA doesn't often move quickly," said Heise. "Lubricants have been loosely regulated anyway, because they're viewed as cosmetic products." "Because we saw the urgency, we wanted to work
collaboratively with manufacturers, and not necessarily have
to get the government regulators involved," she added. "If
we're not able to achieve goals through voluntary action,
we'll look at other schemes." Single-size
diaphragm expands women's protection options CONRAD, a leading reproductive health research organization, announced results of the SILCS Diaphragm contraceptive effectiveness study at the Reproductive Health 2011 conference in Las Vegas, Nevada. The two-year study of 450 US women implemented at six clinical sites in the US showed that effectiveness rates of the new single-size, contoured diaphragm are similar to traditional diaphragms. In addition, SILCS was shown to be easy to use and comfortable to wear. The single-size design eliminates the need for a fitting, which should reduce the amount of time required to provide this method, and opens the potential for providing the method outside of a clinic setting in the future, if allowed by regulatory authorities. Jill Schwartz, MD, CONRAD's medical director and study principal investigator said, "Women and societies worldwide suffer from the consequences of unintended pregnancies. By expanding their contraceptive options with easy-to-use methods that have minimal side effects, we're also expanding the potential for women's overall health, not to mention, their families welfare." She added, "Study participants reported high marks for ease of use and comfort for both women and their partners, which is so important-the only methods that work are the kind that women will actually use." The SILCS Diaphragm was developed at PATH, an international nonprofit organization whose mission is to improve the health of people around the world and validated in collaboration with researchers at CONRAD. Development of the SILCS Diaphragm involved a user-centered design process incorporating input from women, their partners, and providers. This feedback led to an innovative design that is comfortable and easy to use-even for women with no previous diaphragm experience. The SILCS device was developed to improve reproductive health in low-resource settings, where women have a limited range of contraceptive methods and where diaphragms are not currently available. This new diaphragm may also be important for women in developed countries, particularly for women who cannot or do not want to use hormonal methods or an IUD. PATH's Vice President and Senior Advisor for Technologies, Dr. Michael Free said, "High rates of unintended pregnancy and discontinuation of current contraceptive methods suggest that existing contraceptive methods do not adequately meet the reproductive health needs of all women. This newly designed, discreet, and reusable cervical barrier could expand women's options for nonhormonal protection, thereby improving women's reproductive health especially in low-resource settings." Michael Thomas, MD, ARHP Board Chair added, "The Association of Reproductive Health Professionals (ARHP) is honored that CONRAD and PATH have decided to release this pivotal new data at our Reproductive Health 2011 conference. ARHP is committed to advancing multipurpose prevention technologies and is very excited by the promising developments coming out of the SILCS study." Funding support was provided by the US Agency for International Development (USAID) and the Bill & Melinda Gates Foundation. Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany, will be manufacturing the SILCS Diaphragm under license from PATH. Kessel and CONRAD are preparing regulatory applications for Europe and the United States. Regulatory approval as a nonprescription device will be determined on a country-by-country basis according to the local norms and guidelines. Through a phased approach, the product will be introduced at an affordable price in both developed and developing countries. The development of the new device was a response to women calling for a broader choice of contraceptive methods that are under their control, can be easily stopped and started, and nonhormonal, thus eliminating side effects. The diaphragm is also more discreet than a male or female condom and less disruptive of spontaneity. Studies will continue to research its potential as a dual protection method by serving as a delivery device for a microbicide gel that can prevent HIV infection. CONRAD has been developing new methods of contraception for men and women for 25 years. This includes both hormonal methods as well as barrier devices such as the female condom and cervical caps. CONRAD is spearheading regulatory work toward registration of tenofovir gel, the first vaginal microbicide proven to reduce HIV and herpes infection. Reproductive Health is the premier conference in
reproductive and sexual health sponsored annually by the
Association of Reproductive Health Professionals.
![]() * * * Condoms are easier to change than diapers and fail less often that abstinence. Contraceptives should be used on every conceivable
occasion. - Spike Milligan * * *
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