Friday, April 22, 2005

Are You Spongeworthy?

The FDA has just [re]approved the contraceptive sponge:

The Food and Drug Administration on Friday approved U.S. sales of the sponge, which was a popular nonprescription birth control product among women when it was withdrawn from the market in 1995.

The polyurethane sponges, which have been sold by manufacturer Allendale Pharmaceuticals in Canada and over the Internet since March 2003, will be available in the U.S. in two months through a company Web site and in four months at retail drug stores, followed by discount stores such as Wal-Mart Stores Inc.

Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth Co. of Madison. Wyeth, then called American Home Products, had stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned.


Great news, but you need to be fully informed before deciding if this is a suitable method for you.

Here's the short version:

There are three sponge brands available, Today, Protectaid, and Pharmatex. The first two brands contain the spermicide nonoxynol-9 (N-9). Today has the highest dosage of the two, at 1,000 mg.

N-9 use has been linked to an increased risk of HIV (the AIDS virus) transmission. Depending on your unique needs, and risk/benefit analysis, using the sponge may be the best option for you. However, Today may not be the best brand for you.

And here's the [considerably] longer version:

The sponge is part of the barrier group of birth control methods. Other barrier methods are:

  • Condom (unisex, female, male)

  • Cervical cap [soon to disappear from the market]

  • Diaphragm (modified--Dumas, Vimule)

  • Ovès cap

  • FemCap

  • Lea's shield

    Barrier methods prevent fertilization (the union of the egg and sperm); they provide a mechanical barrier between sperm and egg. Most barrier methods are used together with a spermicide. Why? In order to increase the pregnancy protection effectiveness of the method.

    Some spermicides are also microbicidal--they kill microbes, like the ones that cause sexually transmitted infections, or STIs. This confers the added benefit of [partial] STI protection. [Only continuous abstinence provides complete protection. There are also promising spermicidal microbicides in development.] However, some spermicides can cause problems.

    In particular, [s]permicides containing nonoxynol-9 do not protect against HIV infection and may even increase the risk of HIV infection in women using these products frequently*

    *[Since a spermicide is a chemical substance, it can irritate the lining of the vagina/cause lesions. STIs organisms can enter the body through a disrupted vaginal lining. Studies have shown that the spermicide N-9, used frequently and for long periods of time, causes vaginal irritation.]

    There are 3 types of spermicides used in birth control sponges:

    - Nonoxynol-9 (N-9)

    Offers no protection against most STIs and, in higher concentrations, increases the risk of HIV transmission.

    - Benzalkonium chloride (BZK)

    Has microbicidal activity--it kills the organisms that cause STIs, including HIV. BZK is widely used as a disinfectant. Studies have also shown that it tends to cause less vaginal irritation than N-9.**

    - Sodium cholate (antiviral)

    The latest recommendations regarding the use of spermicides containing N-9 are:

  • Products containing N-9 should not be used at all to protect against STIs, including HIV.

  • If you are considering using products containing N-9 you should be aware of, and should carefully consider, the proven risk of using N-9 vs. any potential birth control benefits.

    When it comes to using the sponge, here are some of the facts you need to consider:

    Sponge Overview

    The sponge is a little disc, made of soft polyurethane foam; it comes pre-treated with spermicide. The foam has a consistency similar to that of vaginal tissue (neither you, nor your partner should be able to feel the sponge during sex).

    For all sponge brands: one size fits all, so no fitting is required. [Outside the U.S., the sponge is available OTC.]

    All sponge brands are disposable--you use a sponge only once and then throw it away.

    The sponge starts to work immediately after it's inserted and its contraceptive effect lasts for many hours [12 to 24 hours, depending on which brand you use]. You are protected for this entire period of time, regardless of how many times your partner ejaculates (there's no need to reinsert spermicide).

    The sponge prevents a pregnancy mechanically, by blocking the passage of sperm into the cervix, and trapping sperm, as well as chemically, by releasing spermicide.

    To insert the sponge: introduce it deep into the vagina, so that it fits over the cervix. You can insert it up to 22 hours before intercourse. To remove the sponge: depending on the brand used, pull on foam slots, or grasp it between two fingers, and gently withdraw it from the vagina.

    You must leave the sponge in place [at least 2 to 6 hours, depending on brand] after the last act of intercourse, to allow time for the sperm to be killed. [However, don't leave it in beyond the maximum recommended time.]

    The overall 1st year failure rate, for women who have not given birth (nulliparous), is 9% with perfect use, and 20% with typical use. For women who have given birth (parous) the failure rate is 20% with perfect use, and 40% with typical use. [See also specific brand failure rates.]

    If your partner uses a condom, the sponge's ability to protect you against an unintended pregnancy is greatly improved.

    Advantages/Disadvantages

    Some of the advantages of using the sponge:

  • no fitting required
  • no prescription needed
  • woman-controlled method
  • easy to insert and remove
  • you only use it when you need it
  • no wide-spread body effects
  • you can use it if you've recently given birth
  • you can use it if you are breastfeeding
  • you can leave it in for up to 24 hrs (doesn't interfere with spontaneity)
  • no need to add spermicide
  • unobtrusive
  • possible protection against STIs
  • immediate return to fertility

    Disadvantages of using the sponge:

  • higher failure rate vs. other methods
  • you cannot use it if you have an abnormal Pap, genital lesions or infections
  • you cannot use it if you're allergic to spermicide
  • some brands can not be used immediately after childbirth, miscarriage or termination
  • you cannot use it during your menstrual period
  • small risk of toxic shock syndrome(TSS)***
  • some brands may be messy because they have a lot of spermicide
  • must feel comfortable with touching genital area
  • for brands containing N-9, increased vaginal irritation, which is a risk factor for HIV infection

    ***TSS - a small risk of TSS is associated with the use of all barrier methods. [TSS is a generalized body infection; it occurs in women, men and children and may be potentially fatal.]

    There are 3 sponge brands currently available: Today, Protectaid, and Pharmatex. The first two contain N-9; Pharmatex doesn't. Let's take a closer look at each brand to help you decide which one best fits your needs.

    Today Sponge



    - a foam disc impregnated with 1,000 mg of nonoxynol-9 (N-9)

    - you have to wet it with water before insertion

    - may be inserted up to 24 hours before sex

    - must be left in place for at least 6 hours after the last act of vaginal intercourse (not to exceed 30 hours)

    The estimated 1st year failure rate is 17% with typical use (14% for nullips, 27% for parous women). [According to the manufacturer, perfect use failure rates are 9% for nulliparous women, and 11% for parous ones.] The Today sponge was introduced, in the U.S., in 1983, taken off the market in 1995, and recently [re]approved. It is also approved in Canada.

    The Today sponge does not protect against STIs. In addition, N-9, the spermicide in the Today sponge, has been shown to increase the risk of HIV transmission.

    Advantages:

    - may be left in place for 30 hours
    - extensively studied

    Disadvantages:

    - requires water before insertion
    - sulfa allergy may preclude use
    - contains a high concentration of N-9 (increased risk of vaginal irritation, a risk factor for HIV infection)

    Protectaid Sponge



    - a foam disc impregnated with 5,000 mg of the spermicidal F-5 gel

    - F-5 gel contains 6.25 mg of nonoxynol-9 (N-9), 6.25 mg of benzalkonium chloride (BZK) and 25 mg of sodium cholate

    - may be inserted up to 6 hours, but no less than 15 minutes, before sex

    - must be left in place for at least 6 hours after the last act of vaginal intercourse (not to exceed 12 hours)

    The 1st year failure rate is 23% with typical use. The Protectaid sponge was introduced in 1996, in Canada, and in 2000 in Europe. It is not yet FDA approved in the U.S.

    Like with the Today sponge, don't rely on Protectaid to protect you against STIs, especially HIV. However, unlike Today, there are some studies that show that the F-5 gel might cause less vaginal irritation. [In human studies, the F-5 gel did not cause vaginal irritation up to 12 hours after insertion. The manufacturer also states that the F-5 gel can help prevent irritation caused by intercourse (because the gel forms a protective coating on the wall of the vagina).]

    Advantages:

    - no need to wet it before insertion
    - lower spermicidal concentration reduces vaginal irritation, a risk factor for HIV infection
    - may be able to prevent irritation caused by sexual intercourse

    Disadvantages:

    - may only be left in place for 12 hours
    - not as extensively studied as the Today sponge

    Pharmatex Sponge



    - a foam cylinder impregnated with 60 mg of the spermicide benzalkonium chloride (BZK)

    - may be inserted up to 22 hours before sex

    - must be left in place for at least 2 hours after the last act of vaginal intercourse (not to exceed 24 hours)

    The 1st year failure rate is 19% with typical use. The Pharmatex sponge was introduced in 1984, in Europe. It is not yet FDA approved in the U.S.

    Until large-scale clinical studies are available, this sponge should not be relied upon to offer protection against STIs, especially HIV. [I haven't seen any such studies in the English-language literature, and I don't have equal access to French-/foreign-language studies.]

    Advantages:

    - does not contain N-9
    - does not require water before insertion
    - shorter exposure to spermicide
    - may be used while breastfeeding
    - may be used after a recent vaginal delivery, or termination

    Disadvantages:

    - some users may be sensitive to the spermicide

    Bottom line: For women who are unable to use other methods, having the option to use the birth control sponge is great. Because of the nonoxynol-9, before you use the Today brand, consider that there are alternatives available (Protectaid, and Pharmatex). For women who are using other birth control methods, the sponge is a great backup method.

    Update: Welcome Instapundit, Indiebride, and LiveJournal readers!


    **Mauck CK, Baker JM, Barr SP, et al. A phase I comparative study of contraceptive vaginal films containing benzalkonium chloride and nonoxynol-9. Postcoital testing and colposcopy. Contraception. 1997 Aug;56(2):89-96.

    Richardson BA. Nonoxynol-9 as a Vaginal Microbicide for Prevention of Sexually Transmitted Infections. It's Time to Move On. JAMA. 2002;287:1171-1172.

    Van Damme L. (2000). Advances in topical microbicides. 13th International AIDS Conference, July 9-14, 2000, Durban, South Africa (Abstract WeOr62).

    Hoffman T, Taha TE, Martinson F et al. Adverse health event occurring during an N-9 Gel pilot study: Malawi. 13th International AIDS Conference, July 9-14, 2000, Durban, South Africa (Abstract TuPpC1171).

    Psychoyos, A. Protectaid®: a new vaginal contraceptive sponge with anti-STD properties. In: Mauck C, et al., ed. Barrier Contraceptives: Current Status and Future Prospects New York: Wiley-Liss (1994), pp. 265-270.

    Creatsas G, et al. A multinational evaluation of the efficacy and acceptability of the Protectaid contraceptive sponge. Eur J Contracept Reprod Health Care. 2001 Sep;6(3):172-82.

  • 5 Comments:

    At 2:18 PM, Anonymous Anonymous said...

    My nearly 13-year-old son is a sponge baby. Nothing in the packaging at that time mentioned that this is not a good method for someone who has already given birth. I love my son and am glad (now) that I had him, but my husband pretended to shoot the television with his fingers every time a Today sponge commercial came on the air.

    If you plan to use the sponge, be aware of this limitation.

     
    At 8:06 PM, Anonymous Anonymous said...

    Should also mention that if your cervix is tilted at all
    (as with a retroverted and or retroflexed) uterus it may sit to low to be comfortable, and is more prone to eing disloged. In may not remain over the os during intercourse. The spermicide provides some protection, but the effectiveness of the barrier is reduced.

     
    At 8:04 PM, Anonymous Anonymous said...

    Is there an expiration date for the protectaid sponge..?? i cant find a date on the package but when I open the container it feels a little drier than with previous packages... i dont use them frequently, so I probably should throw these away and buy some new ones huh??? any advice would be appreciated!! thanks in advice...

     
    At 6:41 PM, Anonymous Anonymous said...

    My partner and I used the Protectaid Sponge and were unable to remove it from her afterwords. We had to get it removed by a Physician. Unfortunitly, she is a U.S. citizen and it happened in the U.S. A hospital bill had to be paid and Axcan, the makers of protectaid assumed not only did not accept any responsibility, but also gave us some false advice on what we should of done (by telling us that we should of contacted them, while in the instructions it says to contact a physician) and said we have no case as the product is not offered in the U.S. The product is sold to Americans and Europeans from www.protectaid.ca
    What really bothers us is that we had a very bad experience with thier product and went broke because of it and they offered on appology.
    Unfortunitly we are too poor to take on such an industry.

     
    At 2:54 AM, Anonymous Anonymous said...

    These are NOT methods i would ever choose

     

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