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Diaphragms: Update your clinical knowledge
While it is not in the top tier of contraceptive effectiveness, the diaphragm remains an option as a female-controlled method of birth control. What do you know about this form of family planning?
Use of the diaphragm has changed dramatically in the last two and a half decades, according to data from the 1982, 1995, 2002, and 2006–2008 National Survey of Family Growth (NSFG).1 In 1982, 8% of U.S. women who were using contraception chose the diaphragm. As new methods emerged, use of method declined, By 2006–2008, use of the diaphragm had virtually disappeared from NSFG survey reports; the number was so low analysts termed the figure "does not meet the standard of reliability or precision."1
The diaphragm is used with a spermicide. When it is used in conjunction with spermicidal cream or gel, 16% of women will experience an unintended pregnancy in the first year of typical use; 6% will experience an unintended pregnancy in the first year of perfect use.2
The diaphragm offers several benefits:
However, the method provides no protection against HIV and some sexually transmitted diseases (STDs). A clinician must fit the device. A speculum and bimanual exam is recommended before initiating use. The diaphragm has a higher failure rate than hormonal methods. A Pocket Guide to Managing Contraception recommends that advance emergency contraceptive pills be provided when device use is initiated.4 [To talk with patients about the diaphragm, use a free patient handout from the Association of Reproductive Health Professionals.]
Silicone now norm
Two manufacturers provide diaphragms in the United States: CooperSurgical of Trumbull, CT, which manufactures the Milex Arcing Style Diaphragm and the Milex Omniflex Style Diaphragm, and Ortho-McNeil-Janssen Pharmaceuticals of Titusville, NJ, which manufactures the Ortho All-Flex Diaphragm.
The two styles of Milex diaphragms have been manufactured in silicone for several years. The Ortho All-Flex was previously manufactured in latex; the silicone version replaced it in 2009, says Jeff Christensen, an Ortho spokesperson.
The Milex diaphragms always should be used with a spermicidal gel, according to product literature. The Ortho All-Flex diaphragm always should be used in combination with a spermicidal jelly or cream, its product literature notes.
A Cochrane Review of evidence regarding use of the diaphragm with or without spermicide identified only one randomized controlled trial that met review parameters.3 In that trial, no significant difference was found in the pregnancy rates (with typical use or consistent use) or discontinuation rates between the diaphragm-with-spermicide and diaphragm-without-spermicide groups. A trend toward higher pregnancy rates was noted in the diaphragm-without-spermicide group; however, the study failed to recruit the planned number of participants and consequently was underpowered. Therefore, the study provided insufficient evidence to change the commonly recommended practice of using the diaphragm with spermicide, the Cochrane Review team concludes.5
Spermicide is available
Once a woman receives her diaphragm, what spermicides are available for use with it?
In the United States, Gynol Regular Strength Vaginal Contraceptive Jelly, Gynol II Extra Strength Vaginal Contraceptive Jelly, and Options Conceptrol Vaginal Contraceptive Gel are offered over the counter in several retail outlets, including Walgreens, Wal-Mart, Kmart, CVS, and Rite Aid. The brands were acquired in 2008 by Revive Personal Products Co. of Madison, NJ, from Johnson & Johnson, says Mike Lesser, chief executive officer.
All three products rely on the spermicide nonoxynol-9 (N-9) for efficacy. Gynol Regular Strength contains 2% N-9, while Gynol II Extra Strength contains 3% N-9. Options Conceptrol contains 4% N-9.
In 2007, the Food and Drug Administration (FDA) issued a final rule requiring all manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal N-9 products to include a warning that N-9 does not provide protection against infection from HIV or other STDs. in January 2003, the FDA proposed new warning statements and other labeling information for such products after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N-9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel.6
According to guidance from the World Health Organization, N-9 can be used as a contraceptive, alone or in combination with a cervical barrier method, among women at low risk of HIV/STI infection who use the product no more than once daily.7
The two Gynol jellies and Options Conceptrol gel are not available in Canada. Johnson & Johnson had ceased distribution prior to Revive's acquisition of the products, says Lesser. The company is contemplating re-entering the Canadian market due to interest in the products, he notes.