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.