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Handouts

H14-2 FDA Birth Control Guide
The FDA has approved a number of birth control methods. The choice of birth control depends on factors such as a per-
son’s health, frequency of sexual activity, number of sexual partners, and desire to have children in the future. Failure rates, based on statistical estimates, are another key factor. The most effective way to avoid both pregnancy and sexual- ly transmitted disease is to practice total abstinence (refrain from sexual contact).
Failure rates in this handout are based on information from clinical trials submitted to the FDA during product
reviews. This number represents the percentage of women who become pregnant during the first year of use of a birth control method. For methods that the FDA does not review, such as periodic abstinence, numbers are estimated from published literature. For comparison, about 85 out of 100 sexually active women who wish to become pregnant would be expected to become pregnant in a year. Serious medical risks from contraceptives, such as stroke related to oral contraceptives, are relatively rare. This chart is a summary of important information, including risks, about drugs and devices approved by the FDA for contra- ception and sterilization. It is not intended to be used alone, and a health professional should be consulted regarding any contraceptive choice. Review product labeling carefully for more information on use of these products.
Male Condom, Latex/Polyurethane
FDA Approval Date: Latex: Use started before premarket approval was required. Polyurethane: cleared in 1989; avail-
Description: A sheath placed over the erect penis blocking the passage of sperm.
Failure Rate (number of pregnancies expected per 100 women per year): 11 (a, b)
Some Risks: Irritation and allergic reactions (less likely with polyurethane)
Protection from STDs: Except for abstinence, latex condoms are the best protection against STDs, including HIV
Convenience: Applied immediately before intercourse; used only once and discarded. Polyurethane condoms are avail-
able for those with latex sensitivity.
Availability: Nonprescription
Female Condom
FDA Approval Date: 1993
Description: A lubricated polyurethane sheath shaped similarly to the male condom. The closed end has a flexible ring
Failure Rate (number of pregnancies expected per 100 women per year): 21
Some Risks: Irritation and allergic reactions
Protection from STDs: May give some STD protection; not as effective as latex condom
Convenience: Applied immediately before intercourse; used only once and discarded.
Availability: Nonprescription
Diaphragm with Spermicide
FDA Approval Date: Use started before premarket approval was required.
Description: A dome-shaped rubber disk with a flexible rim that covers the cervix so that sperm cannot reach the
uterus. A spermicide is applied to the diaphragm before insertion.
Failure Rate (number of pregnancies expected per 100 women per year): 17 (b, d, e)
Some Risks: Irritation and allergic reactions, urinary tract infection. (c) Risk of toxic shock syndrome, a rare but seri-
ous infection, when kept in place longer than recommended.
Protection from STDs: None
Convenience: Inserted before intercourse and left in place at least six hours after; can be left in place for 24 hours, with
additional spermicide for repeated intercourse.
Availability: Prescription
Lea’s Shield
FDA Approval Date: 2002
Description: A dome-shaped rubber disk with a valve and a loop that is held in place by the vaginal wall. Covers the
upper vagina and cervix so that sperm cannot reach the uterus. Spermicide is applied before insertion.
Failure Rate (number of pregnancies expected per 100 women per year): 15
Some Risks: Skin irritation, spotting, discomfort (female and male partners), urinary tract infection. Theoretical risk of
Protection from STDs: None
Copyright The McGraw-Hill Companies, Inc. H14-2 (continued)
Convenience: Inserted before intercourse and left in place at least 8 hours after; can be left in place for up to 48 hours,
with additional spermicide for repeated intercourse.
Availability: Prescription
Cervical Cap with Spermicide
FDA Approval Date: Prentiff Cap—1988; FemCap—2003
Description: A soft rubber cup with a round rim, which fits snugly around the cervix.
Failure Rate (number of pregnancies expected per 100 women per year): Prentiff Cap—17; FemCap—23 (b, d, e)
Some Risks: Irritation and allergic reactions, abnormal Pap test. (c) Risk of toxic shock syndrome, a rare but serious
infection, when kept in place longer than recommended.
Protection from STDs: None
Convenience: May be difficult to insert; can remain in place for 48 hours without reapplying spermicide for repeated
Availability: Prescription
Sponge with Spermicide
FDA Approval Date: 1983
Description: A disk-shaped polyurethane device containing the spermicide nonoxynol-9.
Failure Rate (number of pregnancies expected per 100 women per year): 14–28 (d, e)
Some Risks: Irritation and allergic reactions, difficulty in removal. (c) Risk of toxic shock syndrome, a rare but serious
infection, when kept in place longer than recommended.
Protection from STDs: None
Convenience: Inserted before intercourse and protects for repeated acts of intercourse for 24 hours without additional
spermicide; must be left in place for at least six hours after intercourse; must be removed within 30 hours of insertion.
Availability: Nonprescription
Spermicide Alone
FDA Approval Date: Use started before premarket approval was required. Since November 2002, only one active
Description: A foam, cream, jelly, film, suppository, or tablet that contains nonoxynol-9, a sperm-killing chemical
Failure Rate (number of pregnancies expected per 100 women per year): 20–50 (studies have shown varying effective-
Some Risks: Irritation and allergic reactions, urinary tract infections (c)
Protection from STDs: None
Convenience: Instructions vary; check labeling. Inserted between 5 and 90 minutes before intercourse and usually left
in place at least six to eight hours after.
Availability: Nonprescription
Oral Contraceptives—combined pill
FDA Approval Date: First in 1960; most recent in 2003
Description: A pill that suppresses ovulation by the combined actions of the hormones estrogen and progestin. A chew-
able form was approved in November 2003.
Failure Rate (number of pregnancies expected per 100 women per year): 1–2
Some Risks: Dizziness; nausea; changes in menstruation, mood, and weight; rarely, cardiovascular disease, including
high blood pressure, blood clots, heart attack, and strokes Protection from STDs: None
Convenience: Must be taken on daily schedule, regardless of frequency of intercourse. Women using the chewable
tablet must drink 8 oz. of liquid immediately after taking.
Availability: Prescription
Copyright The McGraw-Hill Companies, Inc. H14-2 (continued)
Oral Contraceptives—progestin-only minipill
FDA Approval Date: 1973
Description: A pill containing only the hormone progestin that reduces and thickens cervical mucus to prevent the
Failure Rate (number of pregnancies expected per 100 women per year): 2
Some Risks: Irregular bleeding, weight gain, breast tenderness, less protection against ectopic pregnancy
Protection from STDs: None
Convenience: Must be taken on daily schedule, regardless of frequency of intercourse.
Availability: Prescription
Oral Contraceptives—91-day regimen (Seasonale)
FDA Approval Date: 2003
Description: A pill containing estrogen and progestin, taken in 3-month cycles of 12 weeks of active pills followed by
one week of inactive pills. Menstrual periods occur during the 13th week of the cycle.
Failure Rate (number of pregnancies expected per 100 women per year): 1–2
Some Risks: Similar to oral contraceptives—combined pill
Protection from STDs: None
Convenience: Must be taken on daily schedule, regardless of frequency of intercourse. Since users will have fewer
periods, they should consider the possibility that they might be pregnant if they miss scheduled periods. May have more unplanned bleeding and spotting between periods than with 28-day oral contraceptives.
Availability: Prescription
Patch (Ortho Evra)
FDA Approval Date: 2001
Description: Skin patch worn on the lower abdomen, buttocks, or upper body that releases the hormones progestin and
Failure Rate (number of pregnancies expected per 100 women per year): 1–2 (Appears to be less effective in women
Some Risks: Similar to oral contraceptives—combined pill
Protection from STDs: None
Convenience: New patch is applied once a week for three weeks. Patch is not worn during the fourth week, and woman
Availability: Prescription
Vaginal Contraceptive Ring (NuvaRing)
FDA Approval Date: 2001
Description: A flexible ring about 2 inches in diameter that is inserted into the vagina and releases the hormones prog-
Failure Rate (number of pregnancies expected per 100 women per year): 1–2
Some Risks: Vaginal discharge, vaginitis, irritation. Similar to oral contraceptives—combined pill
Protection from STDs: None
Convenience: Inserted by the woman; remains in the vagina for 3 weeks, then is removed for 1 week. If ring is
expelled and remains out for more than 3 hours, another birth control method must be used until ring has been used Availability: Prescription
Post-Coital Contraceptives (Preven and Plan B)
FDA Approval Date: 1998-1999
Description: Pills containing either progestin alone or progestin plus estrogen
Failure Rate (number of pregnancies expected per 100 women per year): Almost 80% reduction in risk of pregnancy
Some Risks: Nausea, vomiting, abdominal pain, fatigue, headache
Protection from STDs: None
Convenience: Must be taken within 72 hours of having unprotected intercourse.
Availability: Prescription
Copyright The McGraw-Hill Companies, Inc. H14-2 (continued)
Injection (Depo-Provera)
FDA Approval Date: 1992
Description: An injectable progestin that inhibits ovulation, prevents sperm from reaching the egg, and prevents the
fertilized egg from implanting in the uterus.
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks (serious medical risks from contraceptives are rare): Irregular bleeding, weight gain, breast tenderness,
Protection from STDs: None
Convenience: One injection every three months.
Availability: Prescription
Injection (Lunelle)
FDA Approval Date: 2000
Description: An injectable form of progestin and estrogen
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks: Changes in menstrual cycle, weight gain. Similar to oral contraceptives—combined.
Protection from STDs: None
Convenience: Injection given once a month.
Availability: Prescription
Implant (Norplant)
FDA Approval Date: 1990
Description: Six matchstick-sized rubber rods that are surgically implanted under the skin of the upper arm, where they
steadily release the contraceptive steroid levonorgestrel.
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks: Irregular bleeding, weight gain, breast tenderness, headaches, difficulty in removal
Protection from STDs: None
Convenience: Implanted and removed by health-care provider in minor outpatient surgical procedure; effective for up
Availability: Prescription. In July 2002, Norplant’s manufacturer announced that it will no longer distribute the
Norplant system. Women using the system should contact their doctors about what their contraceptive options will be after the five-year expiration date of their Norplant systems.
IUD (Intrauterine Device)
FDA Approval Date: 1976 (f)
Description: A T-shaped device inserted into the uterus by a health professional.
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks: Cramps, bleeding, pelvic inflammatory disease, infertility, perforation of uterus
Protection from STDs: None
Convenience: After insertion by physician, can remain in place for up to one or 10 years, depending on type.
Availability: Prescription
Periodic Abstinence
FDA Approval Date: N/A
Description: To deliberately refrain from having sexual intercourse during times when pregnancy is more likely.
Failure Rate (number of pregnancies expected per 100 women per year): 20
Some Risks: None
Protection from STDs: None
Convenience: Requires frequent monitoring of body functions (for example, body temperature for one method).
Availability: Instructions from health-care provider
Trans-abdominal Surgical Sterilization—female (Falope Ring, Hulka Clip, Filshie Clip)
FDA Approval Date: Early 1970s (g)
Description: The woman’s fallopian tubes are blocked so the egg and sperm can’t meet in the fallopian tube, preventing
Copyright The McGraw-Hill Companies, Inc. H14-2 (continued)
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks: Pain, bleeding, infection, other post-surgical complications, ectopic (tubal) pregnancy.
Protection from Sexually Transmitted Diseases (STDs): None
Convenience: One-time surgical procedure that requires an abdominal incision.
Availability: Surgery
Sterilization Implant—female (Essure System)
FDA Approval Date: 2002
Description: Small metallic implant that is placed into the fallopian tubes. The device works by causing scar tissue to
form, blocking the fallopian tubes and preventing conception. (h) Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks: Mild to moderate pain after insertion, ectopic (tubal) pregnancy.
Protection from STDs: None
Convenience: Minor surgical procedure, permanent sterilization. Device is inserted through the vagina using a catheter.
Women must rely on another birth control method during the first three months, until placement is confirmed with an Availability: Prescription
Surgical Sterilization—male
FDA Approval Date: N/A
Description: Sealing, tying, or cutting a man’s vas deferens so that the sperm can’t travel from the testicles to the penis.
Failure Rate (number of pregnancies expected per 100 women per year): less than 1
Some Risks (serious medical risks from contraceptives are rare): Pain, bleeding, infection, other minor postsurgical
Protection from STDs: None
Convenience: One-time surgical procedure.
Availability: Surgery
(a) Projected from six-month study and adjusted for use of emergency contraception.
(b) If spermicides are used with barrier methods, be sure that the spermicide is compatible with the condom or diaphragm (won’t cause it to weaken or break). Oil-based lubricants (such as petroleum jelly or baby oil) will cause latex to weaken and should not be (c) Spermicides used alone, with barrier devices, or with condoms can cause irritation to the skin lining the vagina, especially when the spermicide is used frequently. There is a possibility that spermicide might increase the risk of acquiring some sexually transmitted diseases because of disruption of the vaginal skin. Spermicide has not been proven to be effective against bacteria and viruses in peo- ple. Therefore, there is no reason to use spermicide during pregnancy.
(d) Medications for vaginal yeast infections may decrease effectiveness of spermicides. (e) Less effective for women who have had a baby because the birth process stretches the vagina and cervix, making it more difficult (f) First approval date of currently marketed IUDs. Some IUDs were sold before premarket approval was required. Those products (g) Sold before premarket approval was required (1976).
(h) A contraceptive option for people who don’t want children. Considered permanent because reversal is typically unsuccessful.
SOURCE: Food and Drug Administration. 2003. FDA Consumer: Birth Control Guide (Updated December 2003) (http://www.fda.gov/fdac/features/19976/babytabl.html; retrieved May 30, 2005). Copyright The McGraw-Hill Companies, Inc.

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