Sole U.S. distributor of cap closes business
Sole U.S. distributor of cap closes business
The options in barrier contraceptives for American women have been reduced as the sole U.S. company distributing the Prentif Cavity-Rim Cervical Cap has announced its dissolution and the device is no longer available in the United States.
The move to dissolve the distribution company, Cervical Cap (CxC) Ltd. of Los Gatos, CA, was made after it was advised that the manufacturer of the device, Lamberts (Dalston) Ltd. of Luton, England, would no longer carry product liability insurance, says Liz Summerhayes, RN, NP, CxC’s chief executive officer. In addition, the manufacturer announced a considerable increase in the cost of the cap and closure of its United Kingdom manufacturing plant, she adds.
Summerhayes, who has been involved with use of the barrier device since its initial U.S. testing in 1981 and approval in 1988 by the Food and Drug Administration, says that while there has been a decline in the interest in the Prentif cap over the years, those who have supported its use have been passionate in advocating the barrier method.
"For women who have really wanted a barrier method, there have been very few options," she notes. The company’s web site, www.cervcap.com, will remain active as a source of product support, she states.
Katy Backes, MPA, executive director of the Cambridge, MA-based Cervical Barrier Advancement Society (CBAS), a nonprofit advocacy group, echoes similar disappointment in the announcement.
"The Prentif Cervical Cap is a safe, effective, female-controlled contraceptive with a long history of use in the U.S., and this product, as well as other cervical barrier methods, offer important contraceptive options to women who prefer a method they can control and those who cannot or choose not to use hormonal methods," she says. "There is an urgent need for more contraceptive and HIV/STI [sexually transmitted infection] prevention options that meet women’s needs, and we regret that American women will no longer have access to this safe, effective contraceptive option."
Look for options
What other female-controlled barrier options are available for American women? Choices include:
- the diaphragm, Ortho All-Flex Arcing Spring Diaphragm and the Ortho Coil Spring Diaphragm, both manufactured by Ortho-McNeil Pharmaceutical, Raritan, NJ, and the Milex Wide Seal Diaphragm, Milex Products, Chicago;
- the FemCap cervical cap, FemCap, Del Mar, CA;
- Lea’s Shield, Yama, Union, NJ;
- the female condom, FC Female Condom, Female Health Co., Chicago;
- the Today contraceptive sponge, Allendale (NJ) Pharmaceuticals.
The diaphragm, FemCap and Lea’s Shield are prescription-only devices; the FC female condom (formerly known in the United States as the Reality Female Condom) and the Today sponge are over-the-counter products. (Get more information on these methods; see the resources, below.)
While diaphragms must be fitted by the clinician, the FemCap and Lea’s Shield do not require custom fitting. The FemCap is available in three sizes: 22 mm, for women who have never been pregnant; 26 mm for women who have miscarried or had cesareans, and 30 mm for women who have vaginally delivered a full-term baby. Lea’s Shield is a "one-size-fits-all" vaginal barrier contraceptive device.
Vaginal barrier methods are simple to use, noninvasive, and may be used intermittently with little advanced planning, according to the authors of Contraceptive Technology. However, consistent and correct use is essential for their effectiveness. Most pregnancies occur because the method is not used.1
As the search continues for female-controlled protection against pregnancy and STI/HIV, renewed focus is being aimed at barrier methods. CBAS, formed in June 2004, is a new initiative stimulated by an emerging global interest in cervical barriers, reports Backes.
"CBAS is an international, professional networking organization including clinical and social science researchers, academic institutions, policy and advocacy groups, program managers, pharmaceutical, biotech, and medical device companies, health care providers, and consumers," she says. "Membership is free and open to all who are interested in joining." (See the resources, below, for contact information.)
Reference
1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 18th revised edition. New York City: Ardent Media; 2004.
Resources
For more information on the Cervical Barrier Advancement Society, contact:
- Katy Backes, Cervical Barrier Advancement Society, P.O. Box 382031, Cambridge, MA 02238-2031. Telephone: (617) 349-0025. Fax: (617) 349-0041. E-mail: [email protected]. Web: www.cervicalbarriers.org. The CBAS web site contains information about cervical barriers, research updates, downloadable materials, and images of cervical barriers. The CBAS web site offers a cervical barrier methods poster, depicting available options. CBAS members and others who are interested can receive free full-size copies of the poster by emailing [email protected] with a shipping address and the number of desired posters.
For more information on barrier options, contact:
- Ortho-McNeil Pharmaceutical. Telephone: (800) 682-6532. Web: www.orthowomenshealth.com.
- Milex Products, 4311 N. Normandy Ave., Chicago, IL 60634. Telephone: (800) 621-1278. Fax: (800) 972-0696. E-mail: [email protected]. Web: www.milexproducts.com.
- FemCap, 14058 Mira Montana Drive, Del Mar, CA 92014. Fax: (858) 792-2624. E-mail: [email protected]. Web: www.femcap.com.
- Yama, 650 Liberty Ave., Union, NJ 07083. Telephone: (800) 699-8130. Fax: (908) 206-8725. E-mail: [email protected]. Web: www.leasshield.com.
- Female Health Co., 515 N. State St., Suite 2225, Chicago, IL 60610. Telephone: (312) 595-9123. Fax: (312) 595-9122. E-mail: [email protected]. Web: www.femalehealth.com.
- Allendale Pharmaceuticals, 73 Franklin Turnpike, Allendale, NJ 07401. Telephone: (888) 343-4499. E-mail: [email protected]. Web: www.todaysponge.com.
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