Mirena Side Effects by the Numbers

Cleveland, OHAccountants love numbers, and are apt to tell many an entrepreneur bent on pursuing the “next big idea” that the numbers simply don’t add up. Could this also be true of Mirena birth control side effects?

“Medical evidence is quite clear that Mirena IUD is one of the absolute safest forms of contraception that’s available today,” said Dr. Thomas Frank, the Director of Family Planning at Metrohealth Medical Center in Cleveland, in comments aired on 7 Action News of Southfield, Michigan (8/27/13). “Mirena is really appropriate for any women who is potentially fertile who doesn’t want to get pregnant.”

But do the numbers support medical evidence that Mirena is safe? The US Food and Drug Administration (FDA), for its part, maintains that no drug or medical product is 100 percent safe, and as long as a product’s benefits for the intended patients or consumers outweigh the risks, then it’s full steam ahead.

But do the numbers tell a different story? According to the media report, over 2 million women have been prescribed Mirena, including patients of Dr. Frank. He has been prescribing the admittedly expensive device since 2001, and patients such as Ally Thompson love it for the convenience. “It’s amazing, it’s so convenient,” said Thompson, who did not identify any Mirena side effects in her particular case. “You don’t have to worry about taking [a] pill every day and it lasts for five years so you can’t beat that.”

But back to the numbers relating to Mirena birth control side effects. When 7 Action News requested copies of the FDA’s own adverse reaction reports on Mirena, the news organization was inundated with over 30,000 pages of documents listing reported problems with the device. Among the findings:

Total complaints since 2000: 70,072

And, since 2008…

Device dislocation: 4,775

Abdominal pain: 3,774

Mirena uterine perforation: 1,322

And those are the reported adverse reactions in the US only, over the last five years. What of those which are never reported? What about Canada, where Mirena is also prescribed? In a 2010 joint statement by Health Canada - the Canadian equivalent to the FDA - and Bayer AG, the manufacturer of Mirena, various Bayer Mirena warnings and side effects were articulated.

The numbers aside, Dr. Frank can’t figure out what all the fuss is about. “I think it’s really a crying shame,” he told 7 Action News. “I think that if you polled physicians, we just don’t have that opinion, that this is a defective product.”

There have been horror stories surrounding the product: Mirena uterine perforations that can cause a woman to be infertile. There has been a report of lacerations to a liver. Mirena migration is common, in one case all the way up to the rib cage.

A woman in Australia has launched a lawsuit in her home country after suffering Mirena uterine perforation during insertion, and the IUD (intrauterine device) became stuck in the wrong position. Ensuing complications have caused the woman to become infertile, and her dream of a large family has been dashed.

What would the number crunchers say of 70,000-plus adverse reactions out of 2 million users? Statistically insignificant? A defensible minority? Perhaps. But is it morally acceptable? A handful of deaths within a large population base could be viewed as statistically insignificant - and it should be noted that there have been no deaths reported from Mirena. But is even one death, for any preventable reason, one death too many on moral grounds? And the impact on women, who can no longer bear children due to the use of a device promoted to them as safe and effective, many view as tragic.

Here’s one more number: 338 lawsuits filed in federal and state court, including multidistrict litigation, as of September 11. The lawsuits are growing.