Watching Women's Health

IUDs – making a comeback

The return of the IUD in the US began when the copper T Paragard IUD was released in 1988. The FDA had approved the product four years earlier, but no attempts were made to sell it in this country until physicians again became comfortable with offering this form of contraception to our patients.

Those of us who trained in the immediate post Dalkon Shield era learned to place IUDs after we were in practice, and we only occasionally recommended them to select patients. (A hormone-releasing IUD, Progestasert, also became available, but was little used because it had to be replaced every year.)

There were many lingering concerns about IUD safety and few women or their physicians considered an IUD as a front-line contraceptive option.

In the past twenty years, these concerns have been adequately addressed by studies that have shown copper IUDs can be used safely in the majority of women seeking contraception. The copper is gradually released in the uterine cavity and acts as a spermicide. The Paragard is approved for 10 years, making it a very long-acting contraceptive.

In 1997, Daniel Mishell, a leading expert in contraception wrote about IUD myths that had been dispelled. He reviewed studies that showed IUDs other than the Dalkon Shield did not increase risk of pelvic infection or ectopic pregnancy.

An important study published in 2001 looked at whether previous IUD use increased infertility in nulligravid women by infecting and obstructing their fallopian tubes. This well-designed study showed IUDs did not increase risk of tubal infertility, but previous exposure to chlamydia did.

That same issue of the New England Journal of Medicine ran an excellent editorial provocatively titled Time to Pardon the IUD?

This pardoning process has been slow. A 2008 California study found 40% of health care providers in the state family planning program did not offer IUDs to women seeking contraception. A significant number of clinicians were not up to date with information on IUD safety and indications for use.

Mirena, a newer hormonal IUD, is changing perceptions about IUDs. Approved for 5 years of use, Mirena has been a highly effective contraceptive and is increasingly being recommended for menses-related problems. Following a few months of spotting after insertion, this progestin-secreting IUD reduces menstrual flow in most women. It has been especially helpful with otherwise hard-to-treat perimenopausal bleeding.

In my experience, most women with Mirenas are very happy with their choice. Over the past several years, I have had to remove only one because a bleeding problem actually worsened. Another of my patients had hers removed shortly after insertion because of persistent pain.

Approximately half of the six million pregnancies in the US per year are unintended. Many unplanned pregnancies occur because of lack of access to contraception and user error with daily or intercourse-related birth control methods.

Today's IUDs, with their good safety records, easy reversibility and 99% effectiveness, could greatly reduce the percentage of unplanned pregnancies. But, before this can happen, physicians and their patients will need to be better informed.

IUDs – what went wrong

The intrauterine device (IUD) is the most popular form of contraception in the world. Today's IUD's are long-acting, reversible, highly effective and safe for the majority of women seeking contraception. In Europe, IUD use ranges from 20-26% of women using contraception and, in Asia, use is even higher.

In the United States, only 2% of women choose an IUD as their contraceptive method. For decades, US women have rarely requested an IUD and physicians have been hesitant to recommend it.  In the last few years, however, the IUD is now making a significant comeback in the US.

After the Dalkon Shield debacle in the 1970's, other IUD manufacturers pulled their products from the US market. No IUDs were sold in the US between 1983 and 1988. Coincidentally, those five years encompassed my residency, and ob/gyn physicians-in-training then learned little about IUDs, except that they were bad. 

Statistical analysis, later found to be flawed, suggested that all IUDs put women at significantly higher risk for pelvic infections. We were not taught how to place them or how to counsel women on IUD risks and benefits.

It now appears that the main problem with the Dalkon Shield was its multifilament tail. (The IUD tail extends through the cervix into the vagina and is used to remove the device.)

With the multifilament tail, infectious organisms could colonize spaces between the filaments and ascend into the uterus and fallopian tubes. Other IUDs have monofilament tails that do not allow this process to occur. Two years after the Dalkon shield was taken off the market, the FDA began regulating medical devices, largely in response to this crisis in women's health.

The Dalkon Shield story is a fasinating, cautionary tale about good intentions gone awry. Physicians were seeking an IUD that would be better tolerated in young women who had not yet been pregnant. 

Instead of getting a better IUD, we got a poorly tested new product with an 8 times higher risk of pelvic infection. In the Dalkon Shield aftermath, a highly effective, and previously safe form of contraception, the IUD, was shunned by physicians and patients in the US and reviled in the press.

The rest of the world continued using IUDs, while the US medical community gradually sorted out fact from apparent fact.  I'll look at those issues in my next post.

Could OC's be an over the counter med?

Recently, I wrote about giving a year's supply of oral contraceptives (OC's) per prescription. Another approach to improving OC effectiveness, discussed at the American Public Health Association annual meeting, was making OC's available without a prescription.

The emergency contraceptive, Plan B , has been available over the counter (OTC) to women 18 and over since 8/24/06. Since this time, no serious medical complications have been associated with OTC use of Plan B.

Most OC's contain an estrogen and progestin, while Plan B is a progestin-only preparation. However, OC's could also gain OTC status.

The FDA has five criteria for a medication to be available without a prescription:

    — benefits outweigh risks
    — misuse/abuse potential is low
    — consumer can self-diagnose condition
    — medication can be labelled adequately
    — health professionals not needed for safe and effective use

OC's clearly meet the first four criteria, and possibly the fifth.  Based on their history, women can adequately screen themselves for OC contraindications, with the possible exception of undiagnosed high blood pressure.

A pilot study in Seattle showed pharmacists could safely dispense OC's. Women filled out a self-screening form and had their weight and blood pressure measured at the pharmacy.

OC's have been available in Mexico without a prescription. Mexican women who started OC's on their own were no more likely to have ignored contraindications than women who had started OC's after visiting a health professional. Also, contraindications to OC's, like untreated high blood pressure, also pose significant risks in pregnancy.

 A 2004 US survey showed 41% of women not currently using contraception would use a hormonal contraception if it was directly available at a pharmacy.

In a British Medical Journal dialogue, Daniel Grossman argues  "the prescription requirement is an out of date, paternalistic barrier to contraceptive use that is not evidence based."

In a counterpoint, Sarah Jarvis says better access to the daily use OC's, with their actual use errors, would not accomplish as much as convincing more women to use long-acting contraceptives.

Would women skip other health services, like pap smears, breast and pelvic exams, and contraceptive counseling, now provided at visits when OC's are prescribed?

Some would, but it appears most would not. Many women, though not needing contraception, visit me annually, recognizing the value of other services I provide.

As unintended pregnancies continue to be a personal and public health concern, we should explore all options for effective contraception. I can see a day in the not too distant future, when OC's could be an OTC med, just like Plan B.

Improving oral contraceptive effectiveness

Among American women using contraception, almost a third choose oral contraceptives (OC's). If a woman takes her OC's perfectly, one pill every day around the same time, her chance of getting pregnant is 3 in 1,000.

For various reasons, many women don't have perfect OC track records. Instead of the 99.7% effectiveness of perfect use, OC's are only 92% effective in actual use.

Somewhat obviously, the main problem is missing pills. Nearly half of women on OC's say they miss one or more pills per cycle. They report being away from home without their OC's, having no new pill pack when needed and simply forgetting to take the pill daily.

The American Public Health Association (APHA) discussed ways to improve OC effectiveness at their last annual meeting.

At the APHA conference, the California Family PACT program [Download Calif PACT OC study pdf] compared dispensing a year's worth of OC's to the usual 1-3 cycles per prescription fill.

For women who received 13 pill packs, OC's had a 97% success rate vs 92% for women who got 1-3 cycles at a time. Having an adequate OC supply allows women to pre-pack an emergency cycle for travel or unexpected overnights, and makes it much less likely they will be without OC's when due to start a new cycle.

The study authors noted women getting a year's supply were more likely to be experienced OC users.

Insurance companies will need to take a long view of their clients' health care needs before they approve giving women a year's worth of OC's per prescription. But taking a longer view is exactly what we need these companies to do.

Women who have been on OC's and plan to continue taking them are a pretty safe bet for a year's prescription. And some unused pill packs are much less costly than an unplanned pregnancy.

Having pills on hand doesn't solve the problem of remembering to take them. For my patients who say they often miss pills, I suggest reminder techniques such as a cell phone alarm. If reminders don't work, then switching to a longer-acting contraceptive is probably the best approach.

In an upcoming post, I'll look at the pros and cons of making oral contraceptives available without a prescription.

Octuplets — surviving birth is just the beginning

The recent birth of octuplets has put a spotlight on assisted reproduction practices in the US. Scientific advances have led to greater success for in-vitro fertilization and other methods. Assisted reproduction is largely responsible for the concerning rise in multiple births in the past 30 years.

Until recently, the press has treated birth of four or more babies like a cool thing, making these families minor celebrities.

Highly specialized physicians do a wonderful job caring for the pregnant mothers and their infants.  Survival rates are amazingly good, but that is just the start of a long series of medical, social and financial problems.

Infertility physicians now have effective approaches to avoid high order multiple pregnancies. Their goal is a live birth of one or two babies.  Even a twin pregnancy carries significantly increased risks for premature delivery and later health problems for the infants.

There's been a lot of criticism leveled at the mother in the octuplet case. Along with most physicians, I lay far more blame at the doctor's door.

The mother does not appear to be a mature personality and an ethical physician would have refused her irresponsible request. The California state medical board is rightly investigating the physician who made the octuplet pregnancy possible.

A few weeks ago I had dinner with friends — two couples, a well-behaved four year old and six month old twins.  The twins had been born several weeks early, as so often happens, but are healthy. 

We five adults had our hands full taking care of the babies, paying some attention to the older child and feeding ourselves. What day-to-day life in the house with 14 children and one mom will be like is scary to imagine.

Best time for elective C-section

Perhaps you've seen reports of a study about increased risks to the newborn with early elective Cesarean delivery. 

The common practice of scheduling a Caesarean (sic) section a little early to make childbirth more convenient sharply increases the risk that babies will be born with potentially serious complications, according to the first large-scale study to examine the dangers. Washington Post

A pregnancy is considered full term after 37 weeks. The American College of Obstetrics and Gynecology (ACOG) recommends elective delivery only after completion of 39 weeks, unless amniocentesis is done to prove fetal lung maturity.

Doctors and their patients sometimes choose a date slightly earlier than the recommended 39 week cutoff and defer amniocentesis since it is an invasive procedure. Common sense might say, after a long pregnancy, a few days more or less can't make much difference. But they do. The large, multicenter study published in the New England Journal of Medicine (NEJM) shows delivery even a short time before 39 weeks has increased risks. 

Among more than 13,000 elective repeat Cesarean deliveries, newborns delivered between 37 and 39 weeks had greater risks of complications than those delivered at 39 weeks.  These complications were mainly respiratory and blood sugar problems, sometimes requiring intensive care and longer hospitalization.

Of course one study is never the complete answer.  As an editorial in the same NEJM issue points out, there can be newborn problems with elective deliveries timed too late in pregnancy.  There is also a 1 in 1,000 risk of death in utero once full term has been reached.  The editorial author points out there has yet to be a study that clearly demonstrates the best elective delivery strategy. For now, it appears the best time to schedule an elective Cesarean delivery is between 39 and 41 weeks. 

During months of prenatal care, obstetricians develop a strong bond with their OB patients. Our patients who will be delivering by C-section often request a particular date to accommodate family schedules, relieve pregnancy discomfort or be sure their own doctor does the delivery.

Though I haven't done OB in recent years. I  recall the temptation to slightly fudge on ideal delivery timing to make one of my patients happy.

When an obstetrician is reluctant to schedule an elective C-section before 39 weeks, it is not due to lack of consideration for the pregnant patient and her family.  Rather it is concern about increased risk to the newborn - risk that can now be clearly  quantified - that prompts caution.

This latest study will help OB docs and their patients balance convenience with safety when putting a C-section on their calendars.