Barrier Birth Control Methods

Feministing links to an article about SILCS, a redesigned diaphragm:

A Seattle-based international nonprofit organization, Program for Appropriate Technology in Health (PATH), is working on a diaphragm redesign, the first ever in the device's 120-year history.

...

The new diaphragm, known as SILCS, tested well in early trials and is poised to enter the market before the end of the decade. Unlike the Ortho All-Flex, currently the most commonly prescribed diaphragm, which comes in nine sizes and requires a woman to undergo a specialized pelvic exam to be fitted with the correct size, SILCS is a "one size fits most" silicone device.

SILCS


Reading the piece [SILCS (.pdf) development started in 1994, and the first trial results were available in 1998] made me realize that it's high time I bring you up-to-date on the actual diaphragm and cervical cap options available.

The following methods are part of the barrier group of birth control:

- Condom (male, female, and unisex)

- Diaphragm*

*There are several types of diaphragms (some available in the U.S.)


Ortho Coil Spring


Flat Spring

- Cervical Cap** (no longer available in the U.S.)

**There are are several types of cervical caps--Prentif (this type used to be available here), Vimule, Dumas.


Prentif


Vimule


Dumas

- Ovès Cap


- FemCap



-Lea contraceptive


[More pics here.]

- Sponges

Bottom line: The only way you can decide which method of birth control is best for you is if you're informed about all the available options, and their pros and cons as they relate to your medical history and lifestyle. So, take advantage of your Ob/Gyn and have him/her go over all the available methods with you.

Condoms: To Use Or Not To Use

Interesting report on condom use:

NEW YORK (Reuters Health) - Many teenagers and young adults fail to use condoms consistently, regardless of whether they have sex with a serious or a "casual" partner, a new study suggests.

Researchers found that among more than 1,300 15- to 21-year-olds, those with casual sex partners had unprotected sex just as often as those in serious relationships -- about 20 times over the previous three months, on average.

Those who had casual sex were more likely to use condoms at least some of the time, the study found. But because they had sex more often, they ended up having unprotected intercourse just as frequently as their peers in steady relationships.

The findings point up two different problems, according to the researchers.

"Unfortunately, this reveals that teens may overestimate the safety of using condoms most of the time with a casual partner and underestimate the risk of unprotected sex with a serious partner," lead study author Dr. Celia Lescano said in a statement.

And, based on my clinical experience, here's a third, quite common, problem: many patients simply do not like using condoms.

Interestingly, I find it's mostly the adults who are adverse to the very concept of condom use. Teens are very receptive to advice on condom use, and the majority report they already use condoms (or so they tell me). But try convincing monogamous adults, in long term relationships, to use condoms. It's not easy, and, I must admit, more often than not, quite unsuccessful.

Where We Hear From the NY Post And We Are Left Wondering What It "All" Means...Er, "Means"

After noticing several factual inaccuracies about Plan B in a NY Post op-ed, I emailed the columnist:

Ms. Wisse Schachter,

I'm contacting you to alert you to a number of factual mistakes in your op-ed. Briefly:

--Plan B is the "emergency contraception pill[s]", or the "postcoital pill[s]", not the "morning-after pill". [That's an incorrect and misleading term.]

--Plan B is not a pill, it's two pills. Two 0.75 mg levonorgestrel pills, to be exact. [Essential information in view of the new dosage recommendations.]

--Plan B is not basically a double dose of the regular birth-control pill. [Even without defining "regular birth-control pill", Plan B is neither a double dose of the regular progestin-only pill, nor of the EC regimen combination one.]

--Plan B is not associated with "cardiovascular disease, high blood pressure, blood clots, heart attack and strokes." (For that matter, neither are the COC EC regimens.) [In fact, Plan B is the preferred EC method for patients with a history of blood clots or stroke.]

(Full post here.)

Thank you for your time.

ema

Today, Ms. Schachter emails back:

Dear Ema,

Thank you for your message and for taking the time to read and respond to my op-ed.

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

It would have been nice had taken as much time reading the column as you did "rebutting" it.

Regards,
Abby Schachter

First, I appreciate the response.

Second, allow me to address this:

It would have been nice had taken as much time reading the column as you did "rebutting" it.

People, as a rule, when emailing me, assume I'm dense and just say what you mean. Not having to divine intent saves me a lot of time.

I'm not sure, but here's what I think Ms. Schachter's admonition means--"I write a piece focused on the political and social implications of OTC availability of Plan B, and you 1) don't address those issues at all, and/or 2) refute them [not] by pointing out, and correcting, the factual mistakes about Plan B." Correct and incorrect at the same time.

Correct, because all I did was address the factual mistakes about Plan B--what it is, it's side effects, etc. My position (and concern) is that, unless we know the basics about a drug, we cannot have an informed discussion about the politics surrounding it.

Incorrect, because, by pointing out the mistakes about Plan B, I was not rebutting anything; I wasn't presenting any opposing evidence to Ms. Schachter's opinions. The facts about Plan B, like its progestin-only content, are not up for debate. It's not a "she said", "she said" situation. We don't each get a few minutes to make our case. Plan B's composition, or side effects for that matter, are a given, independent of anyone's argument/counterargument [you know, the "science" part].

Last, but not least, we have this:

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

Here's the thing [yes, I know, I'm watching way too much Monk]: 1) the side effects listed in the piece are not those commonly associated with taking birth control, and 2) there's nothing even remotely clear [not to mention correct] about Plan B's side effects in the piece.

There are seven groups of birth control, and over eighty individual methods:

1. Hormonal Group

-Combination Pill

-Progestin-only Pill

-Skin Patch

-Vaginal Ring

-Implants

-Shots

-[Hormone-releasing IUDs]

2. Nonsteroidal Pill Group

-Centchroman

3. Intrauterine Device Group

-Older IUDs

-Frame IUDs

-Frameless IUDs

-[Hormone-releasing IUDs]

4. Barrier and Spermicide Group

-Condom (male, female, and unisex)

-Diaphragm

-Cervical Cap

-Ovès Cap

-FemCap

-Lea contraceptive

[Good pics here.]

-Sponges

-Spermicides

5. Natural Family Planning Group

-Continuous Abstinence

-Outercourse

-Sexual techniques

-Breastfeeding

-Fertility Awareness

6. Sterilization Group

-Male

-Female

7. Emergency Contraception Group

-Combination Pill

-Progestin-only Pill

-Antiprogesterone Pill

-Progesterone production blocker Pill

-IUD

These are the side effects listed in the op-ed:

...mild, such as dizziness, weight gain and irregular periods. ... more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

Ms. Schachter says these are the side effects (emphasis mine) commonly associated with taking birth control. Since we're talking about common side effects, everything after rare (cardiovascular dz, HTN, blood clots, heart attack and strokes) is out.

So we're left with dizziness, weight gain and irregular periods. According to Ms. Schachter, these are the side effects commonly associated with taking birth control. Really? When's the last time your partner's condom use caused you to gain weight?

Okay, I'm being facetious, but you get the point. There's no such thing as side effects ... commonly associated with taking birth control. That's because a method's side effects depend on group, mode of action, dosage, route of administration, risk factors, etc..

Even if Ms. Schachter was only referring to the Hormonal Group when listing the side effects, it's still essential to be accurate.

Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not common side effects of methods in the hormonal birth control group. They are rare effects of some of the methods--the combination (estrogen + progestin) ones--in this group. [To give you an idea ...even deaths due to rare events, such as accidents or homicides, are much more common than deaths due to OC-related adverse events.*]

Moreover, the Hormonal Group and the EC Group are not one and the same. The side effects associated with combination methods in the Hormonal Group differ from those associated with combination methods in the EC Group. Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not side effects--rare or otherwise--associated with combination (estrogen + progestin) EC regimens. [From my previous post: No deaths or serious complications have been causally linked to emergency contraception.]

Last, but not least, Plan B is a PROGESTIN-ONLY method. Its side effects differ from the combination (estrogen + progestin) methods in the EC Group.

Which brings us to Ms. Schachter's assertion that she made it perfectly clear in her piece that the side effects she lists are commonly associated with (?hormonal/?estrogen-progestin) birth control, in general, not Plan B. I disagree, and here's why.

In a piece

...titled 'PLAN B': What Science Can't Tell Us...

...containing the statement But it plainly is all about Plan B...

...focused on issues surrounding the approval of OTC sales of Plan B...

...stating that OTC approval of Plan B is troubling because women could get it without the benefit of a doctor's warning about side effects...

Well, approval raises a host of troubling questions. For one: Since it's only a double dose of regular birth control, women over 18 (or girls with fake IDs) could get "the pill" without a prescription - or a doctor's warnings about side effects.

...personalizing the issue of lack of physician counseling about side effects, if Plan B becomes available OTC, by quoting an Ob/Gyn's concerns about losing the opportunity to present medical issues associated with OTC sales of Plan B...

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception [that would be Plan B] means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" [again, Plan B] if a woman doesn't have to see a doctor to get it.

(emphasis mine)

...where the above paragraph--about Dr. Roston's worries that OTC sales of Plan B would rob her of the opportunity to discuss with women medical issues associated with taking Plan B--is immediately followed by an enumeration of side effects...

Of course, some of the risks are mild, such as dizziness, weight gain and irregular periods. But others are more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

it is not at all perfectly clear that the listed side effects are not those associated with Plan B, but rather those associated with some mythical "birth control".

Bottom line: This is not about Ms. Schachter's opinions on OTC sales of Plan B, or my reading comprehension and/or debating prowess. It's about the duty of a publication like the NY Post to present factually accurate medical information to its readers. Or not; in which case the NY Post should have no objection to publishing my article entitled "Plan B Causes Cooties."


*Dialogues In Contraception. Winter 2002;7(7):4

Condoms Found To, You Know, Prevent Stuff

Okay, that's not quite accurate. More like Condoms Found to Prevent HPV Transmission:

Women whose sexual partners consistently used condoms were 70% less likely to acquire genital human papillomavirus infection than were those whose partners did not, in a prospective study specifically designed to determine whether condoms prevent HPV transmission.

"Even women whose partners used condoms more than half the time had a 50% risk reduction, as compared with those whose partners used condoms less than 5% of the time," reported Dr. Rachel L. Winer and her associates at the University of Washington, Seattle.

Several previous studies have suggested that condom use doesn't reduce the risk of HPV infection in women. Even though these studies were cross-sectional and were not explicitly designed to evaluate condom use....

...

In contrast to those previous studies, the prospective, longitudinal study by Dr. Winer and her associates “"as designed to evaluate more accurately the temporal relationship between condom use and HPV infection," the researchers said (N. Engl. J. Med. 2006;354:2645–54).

They assessed 210 healthy female students aged 18–22 years who had never had vaginal intercourse or who had had first intercourse with a single male partner within the preceding 3 months. The subjects completed a Web-based diary every 2 weeks concerning their sexual behavior and underwent gynecologic examination that included HPV testing every 4 months.

...

During a mean follow-up of 34 months, the subjects' diary data were 91% complete. The 12-month cumulative incidence of a first HPV infection after first intercourse was 37%.

Women whose partners used condoms 100% of the time were 70% less likely to acquire HPV infection than those whose partners used condoms less than 5% of the time, after the data were adjusted to account for the number of new partners the women had and the estimated number of previous partners the men had.

A linear dose-response effect was seen, in which incident HPV infection decreased as the percentage of time a condom was used increased.

A similar inverse association was noted between the frequency of condom use and the incidence of cervical squamous intraepithelial lesions. No incident lesions were detected in women who reported 100% condom use, compared with 14 incident lesions found in women whose partners used condoms less consistently or not at all.

"This trend is consistent with previous data indicating that condom use by their male partners protects some women against high-grade cervical neoplasia and invasive cervical cancer," Dr. Winer and her associates said.

Of note was the finding that among couples with 100% condom use, those who reported having some genital skin-to-skin contact had a similarly low incidence of HPV infection as did those who avoided all genital skin-to-skin contact. This suggests that brief episodes of skin-to-skin genital contact "are not particularly efficient for male-to-female HPV transmission," the researchers added.

The newly sexually active women in this study "reported a yearly median number of instances of intercourse (48) and a yearly median number of new partners (1) that were similar to those reported in a large national survey of a random sample of women of a similar age," indicating that these results are somewhat generalizable. The results may not apply to older women or to those of lower socioeconomic status, however.

Ortho Evra Report Not Ready for Primetime I received a lot of e-mails asking me to comment on last night's ABC Primetime report Call for Increased WarningDo Users of the Birth Control Patch Know Enough About Its Potential Dangers? about the birth control skin patch, Ortho Evra. From the transcript, these are the facts:"Based on our best estimates, less than two per 100,000 women less than the age of 35" will die from complications of the patch, said Dr. Shaun Biggers of New York Presbyterian Hospital in New York.So, we have an estimated risk of death from using the patch of less than 2 per 100,000 women. But 17 deaths and 62 life-threatening complications like blood clots might be related to patch use, according to adverse event reports received by the Food and Drug Administration. The FDA has not concluded its investigation. It says some of those reported deaths may not be linked to the patch and some may be duplications.We have a number of deaths in patch users that may, or may not be related to using the patch. We also don't know what the actual number of deaths is--maybe 17, maybe less--since some may be duplications.The patch has been used by 4,000,000 women.So, if we speculate and assume that 1) the deaths observed so far in patch users were, indeed, caused by the patch, and 2) the number of deaths is actually 17, we have an actual risk of death from using the patch of less than 1 (0.425) per 100,000 women.Conclusion: based on the information provided by the ABC report, it appears that the actual risk of death from using the patch is lower than the estimated risk. Very good news, indeed, for patch users.Of course, the puzzling thing about the report is the disconnect between its message and its facts: the call for an increased warning about the patch's serious side effects in light of the reduced risk of death experienced by patch users. Even if, as ABC reports, you have a lower risk of death from using the patch than previously estimated, once you decide to use the patch, or any birth control method for that matter, you should be aware of its side effects.There are two possible explanations for the disconnect in ABC's report: the facts and figures are wrong and the [speculative] observed risk of death for patch users isn't actually lower than the estimated one, or Primetime is clueless, and/or there's a class action suit against the patch manufacturer in the works, and ABC has decided, for whatever reason, to prime the jury pool with discombobulated reports.I called Ortho-McNeil (908-927-3672), the patch manufacturer, and I'm waiting for them to call back and confirm the facts and figures.Update: The Ortho-McNeil medical info person called back and confirmed the numbers (with the standard disclaimers: link to patch not established, total number of users is an estimate, etc.). And still, the ABC report doesn't make sense.

I received a lot of e-mails asking me to comment on last night's ABC Primetime report Call for Increased Warning
Do Users of the Birth Control Patch Know Enough About Its Potential Dangers? about the birth control skin patch, Ortho Evra. From the transcript, these are the facts:

"Based on our best estimates, less than two per 100,000 women less than the age of 35" will die from complications of the patch, said Dr. Shaun Biggers of New York Presbyterian Hospital in New York.

So, we have an estimated risk of death from using the patch of less than 2 per 100,000 women.

But 17 deaths and 62 life-threatening complications like blood clots might be related to patch use, according to adverse event reports received by the Food and Drug Administration.

The FDA has not concluded its investigation. It says some of those reported deaths may not be linked to the patch and some may be duplications.

We have a number of deaths in patch users that may, or may not be related to using the patch. We also don't know what the actual number of deaths is--maybe 17, maybe less--since some may be duplications.

The patch has been used by 4,000,000 women.

So, if we speculate and assume that 1) the deaths observed so far in patch users were, indeed, caused by the patch, and 2) the number of deaths is actually 17, we have an actual risk of death from using the patch of less than 1 (0.425) per 100,000 women.

Conclusion: based on the information provided by the ABC report, it appears that the actual risk of death from using the patch is lower than the estimated risk. Very good news, indeed, for patch users.

Of course, the puzzling thing about the report is the disconnect between its message and its facts: the call for an increased warning about the patch's serious side effects in light of the reduced risk of death experienced by patch users. Even if, as ABC reports, you have a lower risk of death from using the patch than previously estimated, once you decide to use the patch, or any birth control method for that matter, you should be aware of its side effects.

There are two possible explanations for the disconnect in ABC's report: the facts and figures are wrong and the [speculative] observed risk of death for patch users isn't actually lower than the estimated one, or Primetime is clueless, and/or there's a class action suit against the patch manufacturer in the works, and ABC has decided, for whatever reason, to prime the jury pool with discombobulated reports.

I called Ortho-McNeil (908-927-3672), the patch manufacturer, and I'm waiting for them to call back and confirm the facts and figures.

Update: The Ortho-McNeil medical info person called back and confirmed the numbers (with the standard disclaimers: link to patch not established, total number of users is an estimate, etc.). And still, the ABC report doesn't make sense.