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PubMed1993

"Female condom" approved.

The Food and Drug Administration approved the first so-called female condom on May 7. Despite limited data on the effectiveness of the Reality Vaginal Pouch in sexually transmitted diseases (STDs) and a relatively high pregnancy rate among users, the device was approved because it is the first barrier contraceptive for women that provides some protection against STDs. The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice. The panel must also compare the pregnancy rate for the female condom--approximately 26%/year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15%/year. The females condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia. In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal of Jackson, Wis., to take part in additional effectiveness studies for the product. FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on December 10, 1992. Wisconsin Pharmacal studies 200 women who used the device for 6 months. The estimated pregnancy rate of 26%/year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%). Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.

Americas↗
PubMed1993

Helping patients handle accusations of infidelity.

You may have experience with women patients who assume their partners are being unfaithful if they try to use condoms because that behavior could indicate they are trying to prevent potential sexually transmitted diseases (STDs). These same women may believe the same will be assumed of them if they begin to use the new female condom. If women present the device to their partners in the context of a birth control product rather than a device to prevent STDs, men might be more willing to accept it, says sexuality expert Beverly Wipple, PhD, RN, an associate professor at Rutgers State University of New Jersey in Newark and the author of Safe Encounters: How a Woman Can Say Yes to Pleasure and No to Unsafe Sex (Pocketbooks, 1990). Wipple has been a leader in female sexuality research since 1979, having conducted the original research on the "G-spot" (Dell Publishers, 1983). Wipple bases her hypothesis on a presentation about the male condom given at the 1992 annual meeting of the International Society for the Scientific Study of Sex, held in San Diego. The presenter showed that if women were using the male condom as their only form of contraception, then the male was more likely to use it. If the woman was taking oral contraceptives or using another form of contraception--and was only relying on the condom or STD protection--then the male was less likely to use the condom. "I think the same thing might apply to the female condom," Wipple suggests. "If she identifies that this is her method of birth control. I think it is much more likely to be accepted than if she says she is using it to prevent the spread of diseases." Wipple says practitioners should tell women to emphasize the birth control angle and downplay the STD angle. "It may not be the only method they are using, but they don't have to tell him that." she says. "This way, it is not putting an accusation [of infidelity] on him." While she acknowledge and dislikes the lack of honesty inherent in this practice, she says the end justifies the means. "Although it is not addressing the issues that should be addressed, we have to recognize there are people in situations where it is just impossible for them to address the issues," Wipple explains. She says this inability to communicate has led to the spread of STDs.

Attitude↗
PubMed1988

A new IUD.

Explore the source record for details and available documents.

Contraception↗
PubMed1989

[The female condom].

Explore the source record for details and available documents.

Contraceptive Devices, Female↗
PubMed1993

The acceptability of the female condom among low-income African-American women.

Among women, African Americans are at the highest risk for contracting the human immunodeficiency virus (HIV). Unfortunately, the majority of African-American women do not perceive themselves to be at risk nor perceive the need to engage in safe-sex practices. Given the alarming rate of increase of HIV disease among African-American women, more in-depth information about the sociocultural factors influencing these nonhealth-promoting beliefs and behaviors is needed immediately in order to design effective Information, Education, Communication campaigns. As part of such an effort, a premarketing study of the recently developed female condom, Reality (Wisconsin Pharmacal, Jackson, Wisconsin), was used as an opportunity to assess not only acceptance and relevance of the product, but also knowledge, attitudes, and practices among a group of African-American women in New Orleans. The methodology chosen was focus group discussions. The main finding from these discussions is that the previously reported low-risk perception of HIV disease among African-American females is also true among this group. The discussions suggest that cultural norm of female submission and passivity in sexual negotiation is a major barrier to preventive actions among these African-American women, ie, insistence on condom use during sexual intercourse [corrected]. The second important finding from these focus group discussions is that the women enthusiastically endorsed the female condom because they felt this condom allowed them control over safe-sex practices without having to challenge the power of their male partners. This study also demonstrates that the dynamics of universality and interpersonal learning inherent to insight-oriented or support groups can also be present.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗
PubMedDate not supplied

A dose computation model for 241Am vaginal applicators including the source-to-source shielding effects.

A dose computation model has been developed for the determination of dose distributions around vaginal plaque applicators containing encapsulated 241Am sources. Encapsulated sources of 241Am emit primarily 60-keV photons which have a half-value layer thickness of 1/8 mm of lead. This makes possible highly effective in vivo shielding of normal tissues at risk, by placing thin lead shields at appropriate places on the applicator. However, self-absorption of photons in the source material itself is intense, requiring bulky sources of about 1 cm diameter. These sources also produce considerable source-to-source shielding which must be taken into account in dose calculations. Our dose computation model for a single source employs three-dimensional integration of dose contributions from volume elements of the source including the effects of absorption and scattering of photons in the source material, titanium encapsulation, and water. An empirical correction to Berger's data on buildup factors of point, isotropic sources is made to account for the effects of anisotropic photon emission by cylindrical 241Am sources. The second part of our dose computation model takes into account source-to-source shielding effects on both primary and scattered photons for the vaginal plaque geometry. The results of the model have been verified for accuracy by comparisons with extensive dosimetry measurements using lithium fluoride thermoluminescent dosimeters.

Americium↗