May 16, 2003

New Non-Hormonal Low-Cost Birth Control Device Earns FDA Approval

Scripps Memorial Hospital Chula Vista Physician Introduces New Contraceptive

Women now have an innovative new choice in birth control options. Developed by Dr. Alfred Shihata, a Scripps Health physician of Family Medicine at Scripps Memorial Hospital Chula Vista, the FemCap is a new, non-hormonal latex-free contraceptive device. The FemCap was recently granted approval from the Food and Drug Administration.

The FemCap can be worn for up to 48 hours at a time. And, unlike similar birth control devices which can be worn for 24 hours at a time and are not as sturdy and durable, the FemCap, which is environmentally safe, is reusable for two years.

“The FemCap is easy to use and free from side effects. It does not interrupt spontaneity or reduce sexual pleasure because it must be inserted before any sexual arousal,” says Dr. Shihata. The clinical studies were funded by the United States Agency for International Development. “Women have said it is more comfortable than a diaphragm. It is a method that almost any woman can use.”

Made of non-allergenic, medical-grade silicone rubber, the FemCap is a vaginal contraceptive device with an anatomical design that fits over the cervix. This new birth control device protects the cervix and prevents sperm from entering the uterus. It is designed to fit snugly to completely cover the cervix and vaginal vault. This keeps sperm from entering the cervix, thus protecting the wearer from pregnancy.

It also has a unique groove facing the vaginal opening intended to store spermicide. This groove also minimizes any potential for irritation to the cervix and/or the vagina because the bulk of spermicide is stored in this groove and not in contact with the cervix and the vagina, unlike a diaphragm where the spermicide cream will be facing the cervix. The groove serves as a trap for sperm and germs.

Size determination is simple. The FemCap is available in three sizes tailored to the obstetrical history of women. Small is for women who have never been pregnant, medium is for women who have delivered via Cesarean section, and large is tailored for women who have had a full-term vaginal delivery.

An educational videotape and illustrated brochure are provided with each FemCap to help users learn proper placement of the device and to save on the healthcare professional’s time. The FemCap is manufactured by FemCap, Inc., and is not available over the counter. It must be prescribed by a physician, nurse practitioner or nurse midwife. For more information regarding the FemCap, visit www.femcap.com.

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