Category Archives: Family Planning

Maternal Use of Estrogen Hormonal Contraception Just Before Pregnancy – A Risk for Childhood Leukemia?

In a well done and very interesting study in Lancet Oncology, Danish researchers have identified an association between use of estrogen-containing oral contraceptives in the three months prior to pregnancy or during pregnancy and the risk of childhood leukemia in the offspring of that pregnancy.

The study’s conclusions are strengthened by the fact that the data come from three reliable nationwide Danish databases –  one registering births, one registering cancers and the other registering prescriptions –  and included over a million children born between 1996 and 2014, with a median of 9 years follow up from birth.

How high is the risk?

The hazard ratio for childhood leukemia was about 50%-70% higher among children born to women taking estrogen-containing contraceptives in the three months prior to or during pregnancy, compared to that in the offspring of women not using these contraceptives immediately before or during pregnancy. The risk was confined to non-lymphoid leukemias.

Because the overall risk of leukemias is low (most children do NOT develop leukemia), the actual risk translates to one extra case of leukemia for every 50,000 potentially exposed children, or in Denmark, about 4% of leukemia cases over the 9 years studied.

That’s not a large risk, but it is worth looking at.

Which hormonal contraceptives were implicated?

The risk for childhood leukemia was only found for use of estrogen-containing oral contraceptives in the 3 months just prior to pregnancy or during pregnancy. No association was found for non-oral preparations, but there were few cases of these.

No increase in risk was found for ever use of any hormonal contraceptive prior to the 3 months immediately preceding pregnancy.

No risk was found for use of non-estrogen containing hormonal contraception (think the mini-pill, levonorgestrel IUD and Depo-Provera) at any time, even immediately before or during pregnancy.

Is this really true?

Let’s be clear. Association is NOT causation. But it is a signal that warrants further study and a plausible explanation.

In this case there is a biologically plausible mechanism, in that estrogens can inhibit certain enzymes that protect DNA from cancer causing mutations. There are also other proposed mechanisms.

But there could be alternate explanations for the study’s results. For example, what if the mother carries and transmits to her child a genetic predisposition that not only increases the risk of leukemia, but also causes her to have heavy periods that necessitated her use of birth control pills? Or if by chance, in this study, more women with a genetic predisposition happened to take birth control pills? The researchers did not have genetic information on both mother and child, and that’s important.

Results of other studies exploring the birth control pill-leukemia link have been mixed.

So we need further studies.

But still, it begs the question – what should we do until we have the results of these further studies? After all that can take years, and women are getting pregnant now.

What should you do with this information?

What you should NOT do is let this study scare you away from using birth control pills to prevent pregnancy. Oral contraceptives continue to be among the safest, most effective ways to prevent pregnancy. Not to mention their benefits in treating irregular, painful or heavy menses, endometriosis, acne, hirsutism and in some women, PMS.

But until we have further data, I don’t see any harm in playing it safe – which means stopping estrogen-containing hormonal birth control and using either the mini-pill or a barrier method of birth control (such as condoms or diaphragm) in the 3 months prior to attempting pregnancy.  (Theres no reason to change to a long acting method such as Depo-Provera or the IUD for just 3 months.)

If you’re an inconsistent oral contraceptive user worried you may become pregnant due to missed pills, this may be another reason why you may want to change to a more effective method such as the IUD for long term use.

As they say, talk to your doctor.  

With my own patients, I tend to take an “If it’s not broken, don’t fix it” approach to birth control. Which means, if you are happy and healthy using estrogen-containing birth control, don’t let this be a reason to stop using it. But do have a plan for transitioning off when you want to become pregnant.



  • Pombo-de-Oliveira MS. Maternal hormonal contraception and childhood leukaemi. Comment. Lancet Oncology 19:10. p1261-1262. Oct 1, 2018.
  • Hargreave M, Mørch LS, Andersen KK, Winther JF, Schmiegelow K, Kjaer SK.
    Maternal use of hormonal contraception and risk of childhood leukaemia: a nationwide, population-based cohort study.Lancet Oncology. 2018; (published online Sept 6.

Title X – Free Speech Under Fire. Again.

It’s deja vu all over again, as the current administration, borrowing a never-implemented move from the Reagan administration, attempts to gag physicians who provide reproductive care to women.

New proposed regs would forbid Title X funded providers from freely providing information about abortion to their patients, limiting such conversation to the provision of a list of names to women who have already decided to have an abortion.

Given that close to 50% of pregnancies in the United States are unplanned and that a significant proportion of women with unplanned pregnancy are unsure what they will do at the time of diagnosis or presentation to their doctor, the ruling is effectively a gag rule for any encounter around unplanned pregnancy. Or a planned pregnancy that goes wrong. Or that occurs in a woman with medical issues placing her health in danger during pregnancy. Or anytime when a pregnant woman is unsure what she wants to do regarding her pregnancy.

There’s more to the ruling that just the gag, much of it targeting Planned Parenthood, which provides reproductive health services to 41% of Title X clients.

By imposing extensive physical and financial separation requirements, the proposed rule effectively excludes from Title X any safety-net health center that provides abortion using non-federal funds. Specifically, Title X-funded entities would have to maintain separate accounting records, physical spaces (such as waiting and exam rooms, entrances, and exits), workstations, phone numbers, email addresses, staff, patient health records, educational programs, and signs.

The Ruling also lowers the bar and redefines family planning to allow Title X Funds to flow to programs that don’t actually offer medically approved contraception, but instead focus only on fertility awareness (rhythm), adoption or abstinence.

If you, as I do, oppose the proposed Title X changes, then I urge you to submit a formal comment and make your voice heard.

You’ll be joining the AMA, AAP, ACOG and ACP and almost 600 bipartisan elected officials in opposing this attempt to limit the free flow of healthcare information to women seeking to make choices among legal medical options. If you’re not great with words, head over to PRH Website for some more freely given text.

Here’s the comment I submitted today. Feel free to share, copy and paste.

Dear Secretary Azar, Senior Advisor Huber, and Deputy Assistant Secretary Foley:

I am writing you at this time to express my strong opposition to the proposed changes to Title X funding rules, which would limit Title X-funded providers in dispensing information or referrals for abortion services.

The proposed rule effectively gags both health care providers and their patients, limiting free speech within the patient-provider relationship.

Many, many women at the time of pregnancy diagnosis are unsure of their plans for that pregnancy, and wish to discuss their options with their provider. Limiting abortion discussion and referrals to women who have already decided to have an abortion is tantamount to malpractice, as women who are unsure of their options are not provided by their clinician with the critical health information they need to make a choice between the legal options available to them.

As a practicing physician I vehemently oppose this attempt to dictate medical care. Abortion is a legal medical procedure, safer than carrying pregnancy to term when performed by qualified providers, and information about it must be freely available to women, who need unbiased, factually correct, evidence-based information to make the choices that are safest and best for themselves and their families.

The proposed regulations unfairly and unconscionably impacts low income women, who frequently have no other options for reproductive health care other than that provided by Title X providers. The proposed rule changes create a two tiered system of reproductive education and care – one for women of means, who are given the information and counseling they need to make decisions about their reproductive health, and the other for poor women, from whom information about legal, safe reproductive options is deliberately withheld. If the legislation has its intended impact, women will lose trusted providers such as Planned Parenthood, which currently provides care to 41% of Title X patients.

Finally, the government cannot, though its funding mechanisms, require physicians to deliberately withhold information about completely legal health care options from our patients.  This violates our free speech, promotes unethical behavior and violates the patient-physician relationship.

I urge you to withdraw the proposed changes

Thank you for allowing me to comment.


Margaret Polaneczky, MD


More reading

The Caya Diaphragm – What You Need to Know to Prescribe or Obtain It

A new diaphragm has become available in the United States – It’s called Caya, and it’s available in a single size and by prescription only, and is designed to be used with a nonoxynol-9 contraceptive gel.

Caya was developed as a collaboration between PATH and CONRAD, two non-profits responding to the needs of women for easy to use, effective, non-hormonal, user controlled contraception. Researchers at CONRAD, in a user-centered design process, worked their way  through over 200 different prototypes to arrive at the current one-size, non-latex diaphragm, which was initially called the SILCS diaphragm. The SILCS diaphragm was evaluated in research studies in the US and internationally, and proved not only to be equally effective to currently marketed diaphragms, but also easy for women to learn to insert and remove. The diaphragm was licensed to Kessel in 2010, who now markets  it as Caya in over 25 countries.

Caya was FDA-approved last year and will now be distributed in the US by HPSRx.


The diaphragm is a great option for women unwilling or unable to use hormonal contraceptives or the IUD, and who are motivated enough to use a method with every act of intercourse. Breastfeeding women are a group who may especially like the hormonal-free aspect of the diaphragm.


The diaphragm is by no means the most effective contraceptive available. If 100 women use it for 12 months, 17.8 with will become pregnant; with perfect use, there will be 14 pregnancies. However, in motivated married couples, efficacies close to 95% have been reported with previous diaphragms, a fact I can attest to, having been a highly successful diaphragm user myself for many years.

User coaching could make a difference in efficacy – in Caya clinical trials, correct insertion increased from 76 to 94%. when users were coached rather than simply given written instructions.

Combining the diaphragm with use of the male condom brings contraceptive efficacy close to 100%. Combining it with fertility awareness could also increase efficacy, as women using fertility awareness would avoid intercourse or use a condom during more fertile days. I would predict that breastfeeding women, whose fertility is lower to start with, probably will experience high rates of contraceptive efficacy with Caya.


Caya is available by prescription only. The cost is $85. Spermacidal jelly is extra – cost for this will depend on where you buy it and how often you have intercourse and need to use it.

  • Prescribers.  Although Caya does not require a traditional fitting visit, clinicians can order free “Try Before You Buy’ disposable test units to be sure patients are comfortable using Caya and know how to insert it.  Those clinicians who want to stock and sell Caya directly to their patients can order it directly from HPSRx. Otherwise they can simply write their patients a prescription and fax it to the pharmacy or give it to the patient.
  • Patients: You have three options for obtaining Caya  –
    • Your Clinician. You clinician may stock Caya and be able to sell it to you directly.
    • Your Local Pharmacy – Get a prescription from your clinician and take it to your local pharmacy. Your pharmacist may have to order Caya if they do not have it yet in stock.
    • Mail Order – Get a prescription from your clinician and send it by mail with an order form to either American Mailorder Pharmacy ($80 plus $5 shipping) or Health Warehouse pharmacy ($85 w/ free shipping) , two mail order pharmacies who are stocking Caya for distribution. (Click the pharmacy link for the order form and address). You can also order spermacidal jelly along with your diaphragm, but it’s cheaper to get it from other vendors..

Don’t foget spermacidal gel.

Caya won’t work without it.

Spermacidal Gel is available without a prescription at pharmacies and online. The manufacturer is offering Options GYNOL II Gel or Contraceptrol pre-filled applicators at a cost of $18.50 and $17.50, respectively. By comparison, the cost of these spermacides is between 11 $11 and $15 from most online vendors, plus shipping.

Use of nonxynol-9 spermacidal gels can increase HIV transmission rates if you’re exposed to an HIV infected partner. I’d recommend that you and your partner have negative HIV testing before considering giving up condoms and moving to the diaphragm for birth control.

How to Insert Caya

Instructions are here.  The manufacturer also has a video.



Learn how Caya was developed – a  story of innovation and collaboration between non-profit and for-profit sectors.

Removing the Fallopian Tubes to Prevent Ovarian Cancer – Something to Consider

Uterus Tubes and OvariesNew information strongly suggests that most ovarian cancers originate, not in the ovary, but in the fallopian tube. If this is so, then removal of the fallopian tubes may actually prevent ovarian cancer.

The evidence is powerful enough that the American Congress of Obstetricians & Gynecologists is now recommending that fallopian tube removal be considered in women planning to undergo surgical sterilization or hysterectomy.

The Fallopian Tube Origin of Ovarian Cancer

We used to think that ovarian cancer originated in the peritoneal lining that covers the ovaries and abdominal organs. But the fallopian tube origin of ovarian cancer makes so much more sense when you consider what we know about ovarian cancer.

Think about it. The fallopian tube is an open tube that almost caresses the ovary at its distal end, where it is open to the abdominal cavity. Its blood supply is intimately shared with the ovary, and its inner surface is bathed in fluid that it shares with the fluid of the abdominal cavity. According to the theory, cancerous cells arise in the fallopian tube from small precancerous precursor lesions, where they grow undetected until they metastasize to the nearby ovary, or to the abdominal wall and surface of the pelvic and abdominal organs.

This goes a long way to explain why ovarian cancer is more often spread beyond the ovary to the pelvis and abdomen  (Stage 3) and not just confined to the ovary (Stages 1 and 2) at diagnosis.

It also helps to explain how ovarian cancer has stubbornly eluded our attempts at screening. Because by the time the ovary appears abnormal on ultrasound, the cancer has already spread beyond its primary site. (Fallopian tubes are not easily visualized on pelvic sonogram.)

Note that the type of ovarian cancer thought to originate in the fallopian tubes is the so-called “serous” ovarian cancer. Serous cancers account for about two-thirds of ovarian cancers.  The other third of ovarian cancers are endometriod and small cell cancers (which are thought to originate in the uterus or within the ovary), mucinous cancers (which may originate in the ovary or in the GI tract), and germ cell tumors (which originate from germ cells in the ovary).

What evidence is  there?

Data a rapidly accumulating to support the fallopian tube origin of ovarian cancer.  Here’s what we know so far –

  • In BRCA positive women at high risk for ovarian cancer, prophylactic removal of the tubes and ovaries finds hidden cancers in 7-15 % of women, but over half of these cancers are in the distal end of the tube, not the ovary.
  • The gene mutations found in serous ovarian cancers are the same ones found in the fallopian tube cancers, and the gene expression of serous ovarian cancer cells is more like that of a fallopian tube cell than an ovarian cell.
  • Scientists have found precursor lesions at the ends of the fallopian tube, that while not cancerous, look an awful lot like ovarian cancer cells.
  • Women who have had their tubes tied have 30% lower rates of ovarian cancer than those with intact tubes. The cancer prevented are the types (clear cell and endometriod) that would seem to originate in the uterus, based on the type of cells in the cancer.
  • Women who have their fallopian tubes removed have a 60% lower risk of ovarian cancer, and the type of cancer prevented are both the types that originate in the uterus and the type that we now think originates at the end of the fallopian tube nearest to the ovary (serous type).

So sign me up, already.

Not so fast.

As safe as it has become, surgery is not without risks.  Operating on every woman to prevent a cancer that few (1% or less) will get may not make sense.

But for women who are already planning to undergo surgery for hysterectomy or tubal sterilization, it is not unreasonable at this juncture to consider removing the tubes while you’re there. This will add little to the risks of the procedure already planned, and may have the potential benefit of preventing ovarian cancer.

What if I am at high risk for ovarian cancer?

At this point in time, the standard of care for prevention of ovarian cancer in BRCA carriers and others at high risk is prophylactic removal of both the tubes and ovaries, a procedure called bilateral salpingo-oophorectomy, or BSO.

But there are downsides to salpingo-oophorectomy for ovarian cancer prevention.  Even though the procedure is usually performed after completion of childbirth, it can cause early menopause, with its own risks of osteoporosis, heart disease and earlier death. If removal of the tubes proves to prevent ovarian cancer, this would be massively important for high risk women, who would have an option for ovarian cancer prevention that will NOT put them into menopause.

Large clinical trials are in progress to determine whether tubal removal will provide the same protection as BSO, but the results of these trials are years away.  If the 60% reduction found in the general population holds up, this may not be a good enough for high risk women, who currently get a 95% risk reduction from salpingo-oophorectomy.

There are reasons other than cancer protection to recommend tubal removal at the time of sterilization

Tubal sterilization is not perfect.

We now know from large longitudinal studies that failures occur more than you’d expect after sterilization, and range from a low of 3.8/1,000 for post partum tubals to as high as 54/1,000 for cautery (burning) of the tube. Failure rates from the Essure procedure are even higher – 96 per 1,000 – that’s almost 10%. Pregnancies that occur after these failed tubals are very likely to be life threatening ectopic pregnancies.

Renowned family planning researcher Mitchell Crenin, MD and colleagues argued persuasively in a recent editorial that the time for sterilization by tubal removal is long overdue. Moreover, if we gynecologists had included women in the discussion from the get go as we began to bandy about sterilization options, including Essure, most women would tell us they want the most effective procedure there is – which happens to be tubal removal.

The recent discoveries of a link between the Fallopian tube and ovarian cancer have brought this issue to the forefront; however, women have not been included in the discussion about their desires, specifically around pregnancy prevention. If failure (pregnancy) is considered a major morbidity, how much more complicated is a bilateral salpingectomy as compared with laparoscopic tubal interruption… the question should not be focused only on ovarian cancer prevention; rather, the more important question should be why we are not offering women a chance for near 100% efficacy by removing the Fallopian tube completely for sterilization.

I’d have to agree.


More Reading

Image by CDC, Mysid [Public domain], via Wikimedia Commons

Ortho Diaphragm Discontinued


It appears as if Janssen Pharmaceuticals has discontinued production of the Ortho All Flex Diaphragm.  That’s not great news for women wanting the full range of contraceptive options.

The good news is that diaphragms are still available in the United States through Cooper Surgical. It’s a wide seal diaphragm, which may not be suitable for all women, but will probably fit most. Your doctor will have to get a fitting set for this particular diaphragm, and once your size is determined, order it for you rather than you taking a prescription to the pharmacy.

If you happen to be in Europe, you can get a Caya Diaphragm without a prescription.

I suspect the market for diaphragms was just too small for Jaansen to keep it going. I’ve only fitted one woman for a diaphragm in the past 6 months.

That’s a real shame, because the diaphragm is an important contraceptive option for motivated women who can’t or don’t want to use hormones or IUD’s.  When used properly by motivated couples, efficacy can be quite high.  I know – I was a long time diaphragm user, and despite being quite fertile, never had an unplanned pregnancy.

Here’s hoping that the Caya manufacturer will step into the US breach and get the diaphragm back into the hands of women who want to use it.


More about the diaphragm from

Even More on Nuvaring and Clot Risks


Merck, the makers of Nuvaring, have announced that they will settle the lawsuits pending against them from women who claim harm from using the ring.  It may be a wise business decision, but surprising given the two recent studies that, unlike the large Danish study published in 2012, find no increased blood clot risk among new users of the Nuvaring compared to women who use older birth control pills.

I’ve updated my prior post on the Ring to address the newer more reassuring data, and point you to this wonderfully written article in the NPR Shots blog for the best summary of the evidence and opinion to date.

Bottom Line

All estrogen containing contraceptives can increase the risk of blood clots. Nuvaring’s risk may or may not be higher than that of older pills containing the protesting levonorgestrel, and more in line with that from desogesterel or drosperinone (YAZ, Yasmin) containing pills.  However, the preponderance of data at this point suggest that the ring’s risks are not higher than that of older pills. Time (and perhaps more studies) will tell if this will change.

For women unable or unwilling to accept the small but real risk for clots from using estrogen containing contraceptives, there are plenty of great, and sometimes even more effective, methods out there – IUDs, progesterone only pills, shots and implants.

Time to Revise Medicaid’s Sterilization Policy

NYSTATE sterilization form
NY State Sterilization Consent
(Click to view full size)

In a well-timed editorial in this week’s New England Journal of Medicine,  Sonya Borrero, MD and colleagues take on Medicaid’s outdated and discriminatory policy on sterilization.

That policy requires a 30 day waiting period after signing a sterilization consent  that then expires 180 days from being signed. Which can sound reasonable till you understand that most sterilizations occur immediately after giving birth in the hospital using consents that must be signed in the prenatal period. And that women with commercial insurance have no waiting period between signing consent and having their tubes tied.

Unfortunately, not every woman who wants sterilization gets her act together to sign the consent in the right time window or remembers to bring the signed consent with her when she is in labor. Especially women on Medicaid, who often have spotty or disrupted prenatal care, and frequently transfer care due to rapidly changing home and work situations. Every Ob-Gyn can tell you about the sterilizations they could not do because their patient forgot the form or just missed the signing window, the form was completed improperly or even worse, never made it to the labor floor from the clinic. 

Sterilizations policies have outlived their initial intent

The authors point out that while the Medicaid’s original policy was created as a deliberate barrier to coerced sterilization at a time when women needed these protections, current informed consent laws provide more than adequate protection against forced sterilization. Medicaid’s policy has outlived its usefulness and has become nothing more than a barrier to care that discriminates agains the very women who would most benefit from having those barriers removed – low income women.

Women who can barely take time away from work of childcare to have a baby, let alone come back 6 weeks post partum for an outpatient tubal ligation and recovery because their consent form wasn’t signed in the right time window.  Women who only get insurance coverage because they happen to be pregnant, but lose it (and birth control coverage) once they are post partum. 

The resultant costs are enormous 

It should come as no surprise then, that almost half  of women who request sterilization but fail to get it become pregnant again within a year of giving birth – twice the rate among women who did not request sterilization. The resulting cost? It’s enormous. 

In a recent cost analysis, we found that Medicaid-policy–related barriers lead to approximately 62,000 unfulfilled requests for postpartum sterilization annually, resulting in an estimated 10,000 abortions and 19,000 unintended births in the subsequent year, at a public cost of $215 million

The consent form itself is confusing and does not support informed reproductive choice

Borrero and colleagues also argue that that the current Medicaid sterilization consent is way too wordy and confusing, leaving significant numbers of women who sign it actually unaware that the procedure is considered permanent and irreversible.  

In one study assessing women’s knowledge about sterilization after they had been given the Medicaid consent form for review, more than one third of respondents (34%) answered incorrectly when asked about the permanence of sterilization. When a modified, low-literacy version of Title XIX-SCF was compared with the current form in a randomized trial involving 200 women with Medicaid coverage, those who reviewed the modified form were more likely to know about the 30-day waiting period before the form is considered valid (a 24-percentage-point difference between groups), that nonpermanent contraceptive options as effective as sterilization are available (an 8-percentage-point difference), and that the procedure is permanent (a 16-percentage-point difference).

Ironic, really, that women are forced to wait a month to have a procedure that they will later regret because the consent wasn’t clear enough in the first place.  Given the wide availability of safe and effective long acting contraception, these women have many more reversible options available to them to prevent pregnancy.  If the consent were to outline such options, it would go a long way toward providing clear informed decision making around family planning. 

A call for a revised policy and consent

The authors call for both shortening or removal of the 30 day waiting period and a clearer consent form that supports informed reproductive decision making. Last year, The American College of Obstetricians and Gynecologists called for similar reforms around sterilization – 

There are unfair differences in consent rules surrounding sterilization procedures based on insurance type. Obstetrician–gynecologists should advocate for fair and equitable access for women who are enrolled in Medicaid or covered by other government health insurance programs.

I fully support their recommendations.

Nuvaring – Weighing the Risks & Benefits


You’re probably here because you read the recent article in Vanity Fair that highlights the stories of young women who suffered blood clots while using Nuvaring, and asks why this method is still on the market.

You may be wondering whether or not you should stop using the ring, and worried about what risks you’d be taking if you kept on using it.

I’m not going to get into the Vanity Fair article itself, except to say that highlighting individual stories, while making compelling reading, does little to really educate women about their own risks. Making Pharma into the bad guy is also compelling, and given how they behave in general, pretty easy to do.  But compelling reading does not necessarily make for good medical advice. Which is what women really need.

So let’s see if I can help out a bit with that.

As I see it, this issue at hand, is this – are the risk of blood clots, which are inherent in any estrogen-containing birth control method, higher in Nuvaring than in other birth control methods you might choose to use? If so, is that difference big enough for you to consider using something other than the Ring?  Or are the benefits you may get from using the Ring (convenience, compliance, and for some women, steadier hormone levels) enough to outweigh the increased risks?


You need to know a few things before we start.

1. If you have sex, unless you use birth control, you will most likely get pregnant.  The odds are about 80% in a year. So unless you plan on being pregnant, you’ll need to use something for birth control. That something is most effective if it is either hormonal or an IUD.

2. On average, your annual chance of getting a blood clot is about 3 in 10,000 if  you don’t use birth control.  This background risk varies with age, increasing from a low of 0.7 per  10,000 at age 17 to about 6 per 10,0000 at age 45. Other factors can increase your risk even further – genetics, obesity, and varicose veins can double the background risk at any given age.

3. Having a baby is always riskier that using birth control.  The risk of blood clots in pregnancy is the highest risk any woman can take, ranging from 4-28 times the background risk.

4. All estrogen containing birth control methods increase the risk of blood clots. Quantifying that risk is difficult, but it ranges from 3-6 times the background risk, depending on which study you quote and which method you are comparing. The risk is related to both the dose of estrogen (the higher the dose, the higher the risk) and the type of progestin used.

5. First and second generation pills have the lowest clot risk – These pills contain levonorgestrel, norethindrone and norgestimate, and their clot risk is about 3 times higher than the background risk. Newer pills using gestodene, desogestrel and drosperinone  have risks about twice that of levonorgestrel pills, as do the Nuvaring and Patch.  That risk is about 6 times the background risk.

6.  Overall, your chance from dying from estrogen-containing birth control methods is about 1 in a million.  

7. Birth control has benefits as well as risks. Birth control pills, the Ring and the Patch lower the risk of ovarian and uterine cancer. Birth control pills also lowers the risk of colon cancer and do not increase the lifetime risk of breast cancer. Birth control pills, the Nuvaring and the Patch are effective treatments for heavy menstrual periods, endometriosis, PMDD, acne, menstrual cramps and fibrocystic breast disease.

8. If you don’t want to be pregnant, and don’t want the risk of estrogen containing birth control, there are other methods you can use. These include condoms, progesterone only pills, spermacides diaphragm, and IUD. These methods each carries their own set of benefits and risks, but do not cause blood clots.


A large Danish study suggested that the risk for a blood clot among users of the Nuvaring is about twice that of older levonorgestrel-containing pills, and is about the same as that from using the Patch, Yaz or pills containing desogestrel.  Initial data from the FDA in 2011 suggested the same thing.

However, when only new hormonal contraceptive users are studied, that increased risks is not seen. Two newer studies – one funded by the FDA, the other by the ring manufacturer, have shown equivalent risks between the ring and older pills. This data makes mores sense clinically than the Danish study because prior research has shown equivalent estrogen levels in the ring compared to pills.  It is important in studies of clot risk to compare new users to new users, since clot risks are generally highest in the first 6-12 months of hormonal contraceptive use.

At this point (As of update 2/16/14), the FDA has not changed the RING labeling other than to include the data from these last two trials. The manufacturer, however has settled lawsuits pending against it. (See this post for more)


Only you (hopefully with your doctor) can decide if the benefits you are getting from using Nuvaring warrant the risk of clots inherent in all estrogen containing contraceptives. For now, that risk seems that it may not to be larger than that in older pills, at least in two of three studies published to date.

For those who cannot remember to take a pill, or who have gotten pregnant due to missed pills in the past, the convenience of the Nuvaring may far outweigh their concerns about the potential for added risk. I have patients who have been through most of the major pills brands, and only found satisfaction on the Nuvaring. For such women, the relative difference in risk seems small in comparison to the benefit they are getting.

But if you’re considering starting hormonal birth control for the first time, and especially if your are over age 35, most experts would say to start with a low dose levonorgestrel, norethindrone or norgestimate containing pill first. If these pills work for you, why take an additional risk by starting with the Ring (or the patch, or Yaz or a desogestrel pill), even if  that risk is a small one?


Additional Reading

Additional Reading on Clots & Contraception from TBTAM

Birth Control – It Works.


A nice infographic from the Alan Guttmacher Institute.

These simple statistics demonstrate how effective contraceptive use can be. They also categorically refute claims by anti-contraception activists that access to contraception somehow leads to more unintended pregnancies and subsequent abortions.

Birth control works.

So use it.

“Birth control” means any effective method, including condoms, diaphragm, sponge, pills, patches,  implants, rings, shots, and IUDs.  The most effective methods on a population basis are the long acting methods – IUD’s and implants. Which does not mean you should stop your pills if you are an effective pill user, but means that in some women, longer acting methods make for better compliance.

Effective does not include withdrawal, and in most women, timing. Yes, I know – a few of you use timing well.  If so, go for it.  But before you do, remember the old joke – What do they call couples who use rhythm for birth control?


Remove Restrictions on Emergency Contraception

The Reproductive Health Technologies Project is sponsoring a petition to remove the current restrictions on emergency contraception and allow it to be placed on pharmacy shelves next to the condoms.

In December of 2011, the FDA was prepared to make emergency contraception accessible to consumers without restriction, based on more than a decade of medical research and policy debates. Instead, HHS Secretary Kathleen Sebelius overruled the FDA, putting politics ahead of women’s health. Her decision created unnecessary confusion for women and couples at a moment when clarity and timing matter most.

Despite Secretary Sebelius’ December 2011 decision, no evidence suggests that making emergency contraception accessible leads to risky behavior among teens. What it does do is give teens a second chance to prevent and unintended pregnancy so they can stay in school…

Emergency contraception is a safe, effective back-up method of birth control that can prevent pregnancy after unprotected sex or contraceptive failure. A woman is healthiest when she can decide the timing and spacing of her pregnancies. Let’s ensure that any woman who needs EC can get it safely and quickly.

Both the American College of Ob-Gyn and the American Academy of Pediatrics have released opinions supporting over the counter EC Access.

And as I’ve written before, emergency contraception is safer than Tylenol.

‘nuf said. Go sign the petition. (I did)

Birth Control Pills Lower Uterine Cancer Risk

In a study of risk factors for uterine cancer,  prior use of the pill was associated with a marked reduction in risk among women having a prior endometrial sampling-

We observed that OCP use before the benign endometrial biopsy or D&C was associated with more than six times lower likelihood of endometrial cancer. Similar findings in the general population were reported by othe  investigators. Estimated protection with use of OCPs ranged from 20% with 1 year of use to 80% with 10 years of use.

This protective effect of OCPs against uterine cancer is not news to us docs, but bears repeating for the public. Between the recalls, the FDA rulings and the lawyers, women rarely hear anything good about the pill.

More good news about OCPs here.

Birth Control – Clarifying the (Small) Heart Attack & Stroke Risks

In a detailed analysis of a large national health database including over a million women ages 15-49, Danish researchers have clarified how various hormonal contraceptives might affect the risk for heart attack and stroke.

While these events are exceedingly rare in the young population of women using pills, the age at which women use hormonal contraception has crept up. Some women are using pills well into their 40’s and even up till menopause.  So it’s appropriate to take a gander at these vascular risks a bit more closely to ask just how much risk women are taking by using hormonal contraception.

And the answer is – not very much.

Let’s see if I can break it down for you –

The risk of heart attack and stroke is largely age-related, whether you take hormonal contraception or not. Women in their late 40’s having a risk of 6 per 10,000 compared with less than 1 per 10,000  for women under age 25.

Having diabetes, hypertension, hyperlipidemia, arrhythmias and being a smoker elevate the risk of heart attack and stroke. By about a factor of two in women up to age 49. Remember though, that the risks related to these factors will increase with age, so don’t let this low number make you too comfortable.

Taking estrogen containing birth control increases the risks of heart attack and stroke, but those risks are very, very small. Just how small?  If you are age 20 years old and are on the pill with no additional risk factors, your overall risk of a heart attack or stroke is about 100 times less than 1%.  If you are 45 and on the pill, your risk is increased from about 6 per 10,000 to 12 per 10,000, a risk that is about 10 times less than 1%.

The risk of stroke and heart attack from estrogen-containing hormonal birth control goes away when you stop taking it. That’s good, since the age at which women stop needing birth control is around the time heart disease risks start to rise.

The risks for heart attack and stroke are estrogen-dose related. This means that the higher the estrogen exposure, the higher the risks.

Here is a very simplistic rendering of how the vascular risks compared between methods. This rendering may not be entirely correct statistically, but I have to place the data into clinical context, and this works for me –

Vascular risks of Hormonal Contraception

Patch, Ring & 50 ug pills > 30 ug pills ≥ 20 ug pills > POPs > Mirena & Implanon

(POPs = progestin-only pills. ug = amount of ethinyl estradiol)

Overall, the difference in risk between the highest and lowest risk hormonal methods is still quite small. Within a given estrogen dose class, the differences between brands of pills is negligible. In some cases, the risk of a 30 ug pill may be the same or lower than some 20 ug pills.

Noticeably absent from the analysis were the 20 ug norethindrone and levonogestrel pills, my personal go to pills for new pill starts these days.

There is also a new pill being marketed that contains just 10 ug of estrogen. If you’re willing to put up with a bit of breakthrough bleeding and want what this study suggests will be a lower risk of vascular side effects, that pill is sure to be a good choice for you.  I personally like it in the over 40 crowd.

Finally, it’s worth noting how good Yaz looks in this study – it’s a 20 ug pill, and no heart attacks were noted among Yaz users in this study. Their numbers were small relative to other pills, however, and the researchers caution that differences between different formulations of pills of the same estrogen dose were not statistically significant.

Bottom Line

Nothing in life is risk free, and that includes birth control. The good news is that the risks are low, and we now have data that women and their doctors can use in deciding between methods based on vascular risks. Or, as Diana Pettiti, MD, MPH states in her excellent editorial accompanying the article

Women, their physicians, and the public should be reassured not only by the Danish study but by the vast body of evidence from epidemiologic studies of hormonal contraception that have been done over the past five decades. This body of research documents the small magnitude of the problem of arterial thrombotic events in women using combined estrogen–progestin hormonal contraceptives. The research shows that the small risk could be minimized and perhaps eliminated by abstinence from smoking and by checking blood pressure, with avoidance of hormonal contraceptive use if blood pressure is raised.12 With the addition of the Danish data, evidence is now even stronger that progestin-only formulations of hormonal contraception have vascular risks that are undetectable with modern epidemiologic methods. Although hormonal contraception is not risk-free, the evidence is convincing that the low and very low doses of ethinyl estradiol (<50 μg) in the combined estrogen–progestin contraceptives studied by Lidegaard and colleagues — whatever the progestin and whether delivered orally or by means of the patch or the ring — are safe enough.

How you can use this data in making contraceptive choices

If you don’t want vascular risks, however small, stick with a progestin only method. The price you’ll pay is some degree of menstrual irregularity, whether its unpredictable bleeding (Impanon), breakthrough bleeding (POP’s, Mirena, Depo- Provera) or over time, no periods at all (Mirena, Depo-Provera).  Progestin only methods also may not benefit skin the way estrogen-containing methods do, and some (like Depo-Provera) can lead to weight gain.   POP’s have slightly less efficacy that estrogen-containing methods and the other progestin-only methods.

If you’re willing to accept the small but real vascular risks of estrogen containing contraceptives, you can potentially minimize that risk by starting with a 10ug or 20 ug pill. These pills do have higher rates of breakthrough bleeding than the 30 ug and higher methods.  Some studies have suggested that in obese women, more perfect compliance is needed to maintain efficacy with these pills meaning you have less leeway to miss a pill occasionally than a thinner woman. Other studies have suggested that these ultra low dose pills may not be as good for bone protection in teens, who are building bone they will need for their adult lives.

If remembering to take a pill is your issue, and you’re not willing to accept the menstrual cycles changes associated with the long acting progestin only methods, consider the ring or patch.  You’ll be accepting a slightly higher risk of vascular side effects, but if you’re under age 40, those risks are exceedingly low.

If you are over age 40,  progestin-only  methods and the lower dose estrogen-containing methods are good first line choices. Women without risks for heart disease remain good candidates for estrogen-containing hormonal contraception, and the pill in particular can ease the perimenopausal transition.

The above is just a rough outline of one approach to take. There are as many options and choices to make as there are individual woman. Other considerations, such as cost, availability, previous experience with a given method, other medical and gynecologic conditions,  other side effects and personal preference need to be taken into account in making contraceptive choices.


Good reporting on this story

Introvale Recall – The FDA (rightly) plays it safe

A birth control pill packaging error has led to a recall of Introvale, a 3 month birth control pill and generic for Seasonale. The apparent mix-up was that the placebo week was placed in the 9th instead of the 13th row of the pack.

Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.

RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

The FDA is being appropriately cautious, and so should you. Follow their recommendation, especially if you have not been perfectly taking your pills. The pills are not what they should be, and they should be replaced.

But I have to admit, of all the pill packaging errors we’ve had to date, this one worries me the least. Here’s why – Traditional birth control pills have a placebo week once a month without impacting efficacy. So, unless the placebo week in the Introvate pack is one of the first 3 weeks of the pack, its placement elsewhere in the pack should do nothing more than give you an unexpected menstrual period. Certainly a placebo week that occurs after a full 8 weeks of active pills is not something that makes me concerned.

One exception would be a woman who had missed a pills or two just before that placebo week – not you’ve extended the pill free interval beyond 7 days and that’s a pregnancy risk. Which I suspect is one reason why the FDA is being extra cautious with their recommendations. I also suspect they’re making sure they’ve covered the possibility that there could be other issues with these lots.

What’s going on with birth control pill manufacturing these days?

I’ve never seen so many recalls – this is the third one in recent memory for me. All different manufacturers, all different pills. Anyone have any ideas?

Now For the Good News – Depo-Provera Prevents Ovarian Cancer

We’ve known for years that birth control pills protect against ovarian cancer, with an up to 80% reduction in risk with long term use.  Now it appears that use of Depo-Provera may convey a similar benefit.

In a large multicenter case control study in Thailand, published ahead of print in the upcoming issue of the British Journal of Ob-Gyn, use of Depo Provera led to a 39% reduction in ovarian cancer risk. Long term use for three years or more reduced the risk of ovarian cancer by a whopping 83%.  Oh, and by the way, in case you didn’t know it, Depo-Provera also protects against uterine cancer, doing it so well that it is actually used as treatment for uterine cancer.

That’s important information for women using Depo Provera to know, particularly in light of recent media attention to the potential for breast cancer in long term Depo Provera users under age 35.

To put it all into perspective, the risk for breast cancer in women under age 35 is about a 0.2% (1 in 500). The lifetime risk for ovarian cancer is about 1.5% (1 in 66). The lifetime risk of endometrial cancer is about 2.5% (1 in 40). Unlike the possible breast cancer risks, which disappear when Depo-Provera is stopped, the protections against ovarian and endometrial cancer appear to be lifelong.

All of these cancer risks are low in comparison to the risk of unplanned pregnancy, which comprise close to half of the pregnancies conceived each year in the United States. For most women, concerns about raising or lowering cancer risk is not the driving force behind choice of contraceptive.  But on balance, the cancer risk/benefit ratio of Depo-Provera appears to be quite favorable and on par with that of combined oral contraceptives.

For women who need effective birth control, that’s good news.

Depo-Provera Use Does Not Raise Overall Breast Cancer Risk in Young Women

That’s the headline the media should have used when publicizing the results of a recent study comparing Depo-Provera use among women ages 20-44 with or without breast cancer. Because that’s exactly what the study’s authors found.

There was no difference in exposure to Depo-Provera among women with breast cancer compared to controls – about 11% of women in each group had ever used Depo-Provera.

Small Sub-group analysis raised a question

However, the researchers also did what is called sub-group analysis – looking at smaller and smaller groups within the breast cancer study population to see if they could find any women who might have a higher risk from Depo-Provera use, even if the overall group did not.

Before I get to those results, I need to point out that cases and controls, and Depo-Provera users and non-users had significant differences in body mass index, ethnicity, family history, age and pregnancy history – all factors related to breast cancer risk.  In addition, controls had had less mammograms than their counterparts who had breast cancer. There is also a large issue of recall bias at play in studies such as this, since we know that subjects with the disease or condition being studied tend to remember drug exposures better than controls do.

Despite these marked differences between the groups, no statistically significant difference was found between Depo-Provera use in breast cancer patients compared to controls.

BUT, when subgroup analysis was done, there was one group that showed a difference – women who had used Depo-Provera for a year or more within the past 5 years. Here’s the finding that led to the headlines –

However, recent users of DMPA (Depo-Provera) for 12 months or longer had a 2.2-fold increased risk of breast cancer (95% CI: 1.2-4.2).

That was all the media needed to hear, and they were off and running, with headlines such as “Depo-Provera shots tied to breast cancer ” and “Depo-Provera shots double breast cancer risk.” Such headlines fail to convey the overall results of the study in a way that is meaningful to anyone but the lawyers.

The Sub-Group analysis that raised concerns was conducted in less than 100 women

What the media did not tell you was that in this “large study”, the actual number of women in the sub-group that showed this statistically significant and concerning result was extremely small – only 34 controls and 36 cases had used Depo-Provera in the past 5 years. Among these, only 15 and 32 respectively had used Depo-Provera for a year or more in that time!

So there you have it – headlines based on a subgroup analysis of less than 100 women who were poorly matched to start with.

These kinds of studies raise far more questions than they answer

Subgroup analysis is a research tool to look for potential topics for further investigation or to inform questionable findings in the overall analysis. For researchers, this type of analysis can be valuable in defining areas for future larger study. But publicizing the results of a small subgroup analysis as if it were the findings of the larger group mis-represents the strength and reliability of the findings. And in this case, that publicity does nothing more that to frighten women away from using hormonal birth control.

I for one am not changing my prescribing practices around Depo-Provera based on this study. Depo-Provera remains an important contraceptive option for many women, although potential side effects (irregular bleeding, weight gain) limit its acceptability as a first line method for the majority of them.  Overall, about 3% of women who use contraception in the United States currently use Depo-Provera.

The discussion around breast cancer and current hormonal contraception is not new

The magnitude of the risk cited, and it’s relationship to current use of Depo-Provera in younger women, is similar to that which has been reported in the past in studies of oral contraceptives and breast cancer risk.  Specifically with Depo-Provera, the risk that appears in current users in some studies actually disappears with longer term use, suggesting that the mechanism may be acceleration of growth of pre-existing tumors, rather than induction of new cancers over time.

Overall, neither oral contraceptives nor Depo-Provera appear to increase lifetime risk of breast cancer. Both reduce the risk of endometrial cancers, and the pill reduces ovarian cancer risk.

Future research may elucidate better what the effect of medroxyprogesterone acetate, the drug in Depo-Provera and the one studied as hormone replacement in the Women’s Health Initiative, may be on breast cancer risk. For now, that risk has best been defined in post-menopausal women, and not in users of hormonal contraception.


Further reading on Breast Cancer Risks and Depo-Provera

  • Depot medroxyprogesterone acetate and breast cancer. A review of current knowledge. Drug Safety Review, 1996
  • WHO Study showed similar results in subgroup analysis for current use in women under age 35.
  • WHO Memorandum on Depo-Provera and Cancer risks.
  • New Zealand study showing risk with longer term use in younger women, with same limitation of small numbers
  • Pooled Analysis of WHO and New Zealand Studies . JAMA 1995

Conflict statement – In the late 90’s, I published two studies of Depo-Provera acceptance and continuation, one of which was partially funded by small investigator-initiated grant from Upjohn that paid part of my research assistant’s salary, along with an NIH training grant.  I have no current conflicts to report.