Executive Summary
The Caya single-size diaphragm, the first new cervical barrier method to enter the market in more than 10 years, is available by prescription from U.S. healthcare providers.
- Results from the contraceptive effectiveness study indicated 76% of women were able to insert and correctly position the diaphragm simply using instructions. With coaching, 94% of women were able to insert, correctly position, and remove the diaphragm.
- The device is constructed with a silicone membrane that is placed over the cervix and prevents entry of the sperm cells into the uterus. Its flexible rim ensures correct position, with grip dimples to facilitate vaginal insertion. The removal dome is on the front of the diaphragm to aid in removal.
The Caya single-size diaphragm, the first new cervical barrier method to enter the market in more than 10 years, is available by prescription from U.S. healthcare providers.
The device gained regulatory approval from the Food and Drug Administration in late 2014. (Contraceptive Technology Update reported on the approval. See “New year, new device — Offer barrier method option to your patients,” January 2015, p. 4.)
The Caya device, known as the SILCS diaphragm during its development phase, was designed through a unique collaboration between the Seattle-based global health nonprofit PATH, the Norfolk, VA-based reproductive health product development organization CONRAD, the United States Agency for International Development, and other partners. The device was licensed in 2010 to Frankfurt, Germany-based Kessel medintim GmbH. The company has selected Salem, VA-based HPSRx Enterprises to introduce the Caya to the U.S. market. The device already is available in Europe, Canada, Malaysia, and Australia.
Clinical studies indicate the single-size design fits most women who could wear a traditional diaphragm, said Gustavo Doncel, MD, PhD, scientific and executive director of CONRAD, in a press statement. Results from the contraceptive effectiveness study indicated 76% of women were able to insert and correctly position the diaphragm simply using instructions. With coaching, 94% of women were able to insert, correctly position, and remove the diaphragm,1 he noted. The ease of using the diaphragm should make it easier to provide and use consistently, said Doncel.
Who can use the device?
The Caya device is constructed with a silicone membrane that is placed over the cervix and prevents entry of the sperm cells into the uterus. Its flexible rim ensures correct position, with grip dimples to facilitate vaginal insertion. The removal dome is on the front of the diaphragm to aid in removal from the vagina.
Which women are potential users of the Caya device? Along with women who desire to use a nonhormonal method, consider patients who:
- are nursing mothers;
- have a latex allergy;
- desire to use the device in combination with natural methods of contraception;
- opt to use self-determined contraception;
- seek a nonhormonal method between pregnancies;
- wish to use in combination with other methods of contraception, such as condoms;
- or choose to use in case of infrequent intercourse.
Which women should not use Caya? Absolute contraindications include the following:
- application in the first six weeks after childbirth;
- if used previously, diaphragms of size 60 mm or 85 mm and larger have been used;
- acute or chronic-recurrent urinary tract infections;
- infections of the genital organs and the true pelvis;
- pronounced descensus uteri and vaginae;
- cystocele with obliteration of the retropubic niche in the vagina;
- or weakly formed or absent retropubic niche.
Relative contraindications include marked and/or fixed retroversion/retroflexion, as well psychological or somatic difficulties with the application of the device.
Be sure to instruct patients to always use water-soluble contraceptive gels such as Gynol II (Revive Personal Products Co., Madison, NJ) when using the Caya diaphragm. The device is not compatible with silicone-based gels and should not be used with them.
How to get device
Estimated consumer cost for the Caya should be about $80, says Robert Patane, founder of HPSRx Enterprises. Depending on the specific retailer or provider, it could vary from $75 to $90, he notes.
“We have already had some success with the product being covered by many of the insurers with zero co-pay to the patient,” Patane comments. The device can be used for two years from the first application.
When prescribing Caya, clinicians might consider stocking the device in office for direct dispensing. This provides convenience for the patient not having to go to the pharmacy to obtain the device, and it might offer a potential cost savings for the patient if the provider passes along its lower cost. According to Patane, healthcare providers purchasing direct from HPSRx are able to acquire the product at a lower cost due to there being fewer logistic entities involved, which results in fewer additional markups. (See resource listing at end of this story for company contact information.)
“With the provider stocking and supplying the product directly, there is no risk that the patient’s pharmacy will not have the product in stock, eliminating the delay and/or complication of the pharmacy having to source and order the product before filling the patient’s prescription,” notes Patane. “Thus, [this offers] much improved and secure access for the patient.”
If providers don’t wish to stock the device, there are two nationally licensed mail order pharmacies that have product in stock: Warren, MI-based American Mail Order Pharmacy and Florence, KY-based Healthwarehouse.com Inc. Providers can call, fax, or e-script the prescription to these pharmacies for faster service, or patients can mail the written prescription along with the order form. (See resource listing at end of this story for pharmacy contact information. Also go to the Caya healthcare providers’ web page at http://bit.ly/1L76eYm, where PDFs of order forms are available for printing.)
HPSRx Enterprises also offers test units free of charge, which are one-time use disposable units that can be used for demonstration, test fitting, or for the patient to actually try insertion and removal while in the office.
In addition, providers can print a benefits and features handout, as well as a consulting guide and a flyer, from the Caya website, www.caya.us.com. Click on the “Health Care Providers” tab.
- Schwartz JL, Weiner D, Lai JJ, et al. Contraceptive efficacy, safety and acceptability of SILCS, a novel single-sized diaphragm used with contraceptive gel. Contraception 2012; 85(3):327.
- American Mail Order Pharmacy, 23290 Schoenherr Road, Warren, MI 48089. Telephone: (888) 772-3811. Fax: (586) 772-6873. Web: http://www.amoprx.com.
- Healthwarehouse.com Inc., 7107 Industrial Road, Florence, KY 41042. Telephone (800) 748-7001. Fax: (888) 870-2808. Web: www.healthwarehouse.com.
- HPSRx Enterprises, 1640 Roanoke Blvd., Salem, VA 24153. Telephone: (800) 850-1657. Email [email protected]. Web: www.hpsrx.com.
