Diaphragm: Update on this barrier contraceptive
Executive Summary
The female diaphragm offers hormone-free contraception that is female-initiated and female-controlled. Currently available diaphragms require a pelvic examination and fitting to ensure proper size and placement of the device.
• Two diaphragms are available to U.S. women: the Milex Wide-Seal Arcing Style Diaphragm and the Milex Wide-Seal Omniflex Diaphragm, sold directly to physicians through CooperSurgical. Both diaphragms are made of silicone and are available in eight sizes, ranging from 60 to 95 mm.
• The SILCS diaphragm, marketed in European countries as Caya, is the first new cervical barrier method to receive regulatory approval and enter the market in more than a decade. Regulatory applications to the Food and Drug Administration are under way.
The female diaphragm offers hormone-free contraception that is female-initiated and female-controlled. However, it is used infrequently in the United States. It is listed by less than 1% percent of U.S. women ages 15-44 who say they use other reversible methods outside the Pill, male condom, intrauterine device, contraceptive injectable, ring, patch, and implant.1
Currently available diaphragms require a pelvic examination and fitting to ensure proper size and placement of the device. According to Contraceptive Technology, the effectiveness of all barrier methods such as the diaphragm depends on anticipatory motivation at the time of each coital act. Thus the difference between typical use and perfect use is greater than those methods that don’t rely on such attention.2 Typical use rate for the diaphragm is estimated at 12%, with perfect rate estimated at 6%.3
Women who choose a diaphragm must understand that to prevent pregnancy, the diaphragm must be used at every time of intercourse. The diaphragm always should be used with a spermicidal jelly or cream. Women using a diaphragm without spermicide had a pregnancy rate of 29 pregnancies per 100 women within 12 months, while those using a diaphragm with spermicide had a rate of 21 per 100 women.4
Instruct women that the diaphragm may be inserted up to six hours before intercourse. If more than six hours have passed between insertion of the diaphragm and intercourse, additional contraceptive jelly or cream should be inserted. The diaphragm does not need to be removed to insert additional spermicide. Women can fill and insert the spermicide applicator, and they can make sure that the jelly or cream is inserted into the upper part of the vagina. The diaphragm should remain in place for at least six hours after intercourse and should be removed soon after that. After a diaphragm has been used, it should be washed with mild soap and water, and it should be stored in a cool, dry place. A diaphragm should not be used if it looks dry, cracked, or has a tear.5
Options slim in U.S.
Just two diaphragms are available to U.S. women: the Milex Wide-Seal Arcing Style Diaphragm and the Milex Wide-Seal Omniflex Diaphragm. Both are sold directly to physicians through Trumbull, CT-based CooperSurgical, confirms corporate spokesperson Jeanie Fusco. (See resource listing at the end of the article for company contact information.)
Both diaphragms are made of silicone and are available in eight sizes, ranging from 60 to 95 mm. The Milex Wide-Seal Arcing Style Diaphragm has a tension-adjusted spring that curves in one place, while the Milex Wide-Seal Omniflex Style Diaphragm has a distortion-free spring that provides arc no matter where the rim is compressed. Both devices provide increased suction for added protection.
The Ortho All-Flex Diaphragm was discontinued as of December 2013 by Titusville, NJ-based Janssen Pharmaceuticals "because comparable alternative products are available to women," says William Foster, company spokesperson. A similar Ortho product, the Ortho Coil Spring, was discontinued in 2008.
"One-size" device eyed
In June 2013, European regulators granted the single-size SILCS Diaphragm a CE marking, allowing the product to be sold throughout Europe. The launch marks an important step toward expanding nonhormonal contraception options for women worldwide; regulatory applications for the Food and Drug Administration are under way. (To read more about the device, see the Contraceptive Technology Update articles "Multipurpose methods show research advances," February 2014, p. 19, and "New data emerges on one-size diaphragm," December 2011, p. 139.)
Marketed in European countries as Caya, the SILCS diaphragm is the first new cervical barrier method to receive regulatory approval and enter the market in more than a decade. Designed through a unique collaboration between Seattle-based PATH (a global health nonprofit) Norfolk-based CONRAD (a reproductive health product development organization operated through the Eastern Virginia Medical School), the United States Agency for International Development (USAID), and other partners, the device was licensed in 2010 to Frankfurt, Germany-based Kessel Marketing & Vertriebs GmbH (Kessel) to accelerate women’s access to the technology.
Results of the device’s contraceptive effectiveness study, a two-year investigation of 450 women implemented at six clinical sites in the United States, showed that effectiveness rates of the new single size, contoured diaphragm are similar to traditional diaphragms.6 Its single-size design eliminates the need for a fitting. Study results indicate the device is easy to use and comfortable to wear.6
- Guttmacher Institute. Contraceptive use in the United States. Fact sheet. Accessed at http://bit.ly/1n18CUc.
- Cates W, Harwood B. Vaginal barriers and spermicides. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
- Trussell J, Guthrie KA. Choosing a contraceptive: efficacy, safety and personal considerations. In Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
- Jones RK, Fennell J, Higgins JA, et al. Better than nothing or savvy risk-reduction practice? The importance of withdrawal. Contraception 2009; 79(6):407-410.
- How to use the diaphragm. Contraception Report 2002; available at http://bit.ly/1lQWhiG.
- Schwartz J. SILCS pivotal data: implications for MPTs. Presented at the 2011 Reproductive Health conference. Las Vegas; September, 2011.
- To get more information on Milex diaphragms, contact CooperSurgical, 95 Corporate Drive, Trumbull, CT 06611. Telephone: (800) 243-2974. Web: www.coopersurgical.com. n
