FAQ – FemCap

FAQ

Why do I need to replace FemCap each year or two?

It is well established that some yeast or fungal organisms can grow on silicone devices and cause persistent yeast infections. Using a new FemCap each year will minimize the possibility of fungal growth. Even with a yearly replacement, FemCap is safer than other methods and still more economical and environmentally friendly.

In Vitro ingrowth of yeasts into medical grade silicone rubber

What is FemCap?

FemCap is an FDA-approved, non-hormonal contraceptive device. Shaped like a sailor’s hat, FemCap is designed to remain in place during sexual activity to prevent sperm from entering the cervix.

This is a short video which describes FemCap design and use.
(Please note: the description video includes an audio commentary that may not be appropriate for public locations.)

How soft is FemCap?

FemCap is made of soft, latex-free, silicone rubber.

How effective is FemCap?

In clinical trials, the effective rate of the second generation FemCap (the only FemCap approved by the FDA) has been proven to be over 92% successful in preventing pregnancy. It is estimated that FemCap’s success rate may be up to 98% with proper use (e.g. not forgotten, correct placement, not removed too soon) and with emergency contraception (available over-the-counter without prescription) as a backup.

For more information on the effectiveness of FemCap, please visit the following resources:

What is the history of improvement of FemCap ?

While woman-controlled barrier contraceptive devices are the safest, and provide a viable alternative to the condom; they are rarely used due to the lack of options. We developed FemCap to increase choices of female-controlled contraceptives.

Earliest Version
The earliest version of FemCap was clinically tested in 1988; the preliminary clinical trial was published in 1991 and co-authored by James Trussell, Ph.D of
Princeton University.

The pivotal clinical trials were also conducted with this earlier version of FemCap in ten universities in United States from 1995-1997.

Based on this study the FDA approved this earlier version of FemCap to be safe and effective for use by women of childbearing age to prevent or postpone pregnancy. Despite the fact that this earlier version of FemCap was proven to be safe and effective in the pivotal clinical trials, we have learned that this first-generation device had two drawbacks.

First, poor effectiveness rate of the large 30 mm FemCap that is designed for women who delivered vaginally due to frequent dislodgement, and Second difficulty with the removal of FemCap.

  1. To compensate for the poor vaginal tone in women who delivered vaginally, FemCap Inc. increased the dimensions of the brim (pointed by the arrows) on the large 30 mm FemCap. This increased the surface area of contact between the brim and the vagina. This also increased the stability and minimized dislodgment, thus enhancing effectiveness of FemCap in women who delivered vaginally.
  2. Added a strap over the dome of FemCap to facilitate removal.

Second Generation FemCap
The second generation FemCap with the removal strap is the only device approved by the FDA for marketing.

To further enhance the effectiveness of FemCap the FDA:

  1. Strongly advised women to insert FemCap prior to sexual arousal, every time to ensure correct placement over the cervix.
  2. Recommended that women may use a back up method during the learning phase of FemCap.
  3. To use Emergency contraception as a back-up method if needed, in case the woman has not used FemCap or used incorrectly.
  4. Use the instructional video to supplement the verbal and the written instruction.

The Second generation FemCap with the removal strap is the only device approved in European countries in July 1999 and by the FDA in March 2003 for marketing. FemCap has not withdrawn from any market for any reason.

What are the side effects of FemCap?

FemCap is a hormone-free contraceptive device. FDA-approved clinical trials indicate that there are no known local or systemic side effects from the use of FemCap.

How does FemCap compare to hormonal contraceptives?

Safety:

The FemCap causes absolutely no harm to the user.  It is soft, non-invasive, and makes no changes in the physiology of the user. The FemCap is a lot safer and more natural than hormones.

Effectiveness:

Hormonal contraceptives are more effective in preventing pregnancy than FemCap, however the use of emergency contraception (the morning after pill) as a back up to FemCap can effectively compensate for this relative decrease in effectiveness.

To learn more visit these sites:

Does FemCap require custom fitting?

No. FemCap comes in three sizes. Your clinician will determine which size you need based on your obstetrical history.

Women who have NEVER been pregnant will use the 22mm FemCap; women who miscarried, had termination (even after two weeks of pregnancy), or had caesarian section will use the 26mm FemCap; women who have had a vaginal delivery will use the 30mm FemCap. If there is a question or doubt of whether you have ever been pregnant, it is best to use the 26mm FemCap.

This page has more information about FemCap sizes.

Is FemCap easy to use?

Yes, FemCap is easy to use. The average woman can learn how to insert and remove FemCap in a few minutes and master its use in a few days. With practice, insertion can be as easy as putting in a tampon. For easy removal, FemCap has been designed with a convenient removal strap.To make the removal process even easier, you may choose to tie a cotton ribbon loop to the removal strap, as show in image below.

FemCap with cotton loop tied to removal strap

How do I use FemCap?

A woman inserts FemCap like a tampon and places it over her cervix prior to sexual activity. FemCap can be inserted up to 40 hours prior to sexual activity and left in place for up to six hours after. Detailed usage instructions are included with every purchase.

How to use FemCap

 

Can FemCap be used during menstruation?

No, FemCap can not be used during menstruation, as it would impede the natural flow of menstrual fluid.

What about the irritation caused by spermicide?

Spermicides currently available over the counter have been sold for more than thirty years with an excellent safety and effectiveness record. It is true that spermicide can cause irritation when used very frequently and in very high doses. To minimize the irritation caused by spermicide, FemCap is designed with a unique groove facing the vagina. This groove stores the bulk of the spermicide and minimizes irritation or leakage. The storage of the bulk of spermicide in this groove ensures immediate and prolonged exposure of sperm to the spermicide as soon as it is deposited into the vagina.

Does FemCap interrupt spontaneity or interfere with sensation?

No, FemCap does not interrupt spontaneity or reduce sexual pleasure for either partner because it is inserted before any sexual arousal – up to 40 hours prior to sexual activity. Due to FemCap’s unique design and soft composition, the woman cannot feel it at all, and the male partner rarely even notices that it is there.

Does FemCap get dislodged during intercourse?

No. The FemCap is specifically designed with a longer brim that prevents it from being dislodged during intercourse. In order to accommodate different sexual positions, FemCap is DESIGNED to ROTATE, but so long as it covers the cervix,it will prevent sperm from entering the cervix. Proper insertion of FemCap ensures that the cervix remains covered throughout the sexual act.

How do users of FemCap feel about it?

Women who have tried FemCap fall in love with it! You can visit our testimonials page to see what some of them have to say.

How is FemCap different than the Diaphragm?

FemCap is different than the diaphragm in many ways.

  • FemCap is made of a single piece of 100% surgical grade silicon, the diaphragm is made of silicone and metal
  • FemCap is specifically designed to conform to a woman’s anatomy and adjust to changes during intercourse, the diaphragm does not
  • FemCap is designed with an easy-to-use removal strap, removing the diaphragm can result in abrasions
  • FemCap provides up to 48 hours of continuous protection, the diaphragm must be removed after 24 hours

These are just a few of the ways FemCap is different than the diaphragm. For more information on the differences between FemCap and the diaphragm, please click here.

How long can FemCap stay in?

FemCap can remain in place up to 48 hours.

How is FemCap cleaned between uses?

FemCap should be washed thoroughly with antibacterial hand soap and rinsed with tap water, then dried and stored in its container after each use.

Is FemCap cost-effective?

YES!

FemCap is a very cost effective form of birth control. FemCap costs less than $8.00/per month for unlimited use. Compare that with the price of condoms or birth control pills, and you’ll see that this is quite a savings. This level of affordability, combined with the added convenience, effectiveness and safety, make FemCap a great choice for your birth control needs.

How often should FemCap be replaced?

It is recommended that FemCap be replaced every year – sooner if it shows any signs of deterioration. Given the retail price of $89.00, this amounts to about $7.40 per month for effective, non-hormonal birth control!

Can I purchase FemCap over the counter at my local pharmacy?

No, not at this time. Currently, the FDA-approved FemCap is only available for purchase by customers in the United States with a valid prescription provided by a nurse practitioner, nurse midwife, physician’s assistant, or doctor. To learn more about getting FemCap, please click here.

Where can I get more information about FemCap?

To learn more you can:

  • Visit FemCap resource directory, which contains links to articles and publications about FemCap
  • View a 7-minute video demonstrating the use of FemCap (video is available in English, Spanish,German, Italian and Swedish)
    (Please note: the instructional video contains audio commentary and images that may not be appropriate for public locations.)

Does health insurance cover the cost of FemCap?

Yes, if your health insurance covers FemCap.

FemCap is an FDA approved device. FemCap, Inc. will provide a proof of payment to submit to your insurance provider.

FemCap has been added to the California state Family PACT formulary.

Cervical cap (FemCap ) ICD10 Data codes HCPCS 2011 Code A  A4261

http://www.icd10data.com/ICD10CM/Index/C/Contraception%2c_contraceptive#407F

Use the following NDC Codes for reimbursement:

FemCap 22mm………………………………………………NDC 08454-0001- 22
FemCap 26mm………………………………………………NDC 08454-0002- 26
FemCap 30mm………………………………………………NDC 08454-0003- 30

For Clinicians use the following CPT codes for services:

Initial Office Visit, Annual Examination99243
Follow Up Visit99214
Cervical Cap Fitting57170
Contraceptive Supply Cervical Cap Device (unspecified)99070

Diagnostic ICD-10 Codes:

General Contraceptive Counseling (Family Planning)Z30.0
Initial prescriptionZ30.018
UnspecifiedZ30.019