K. was in the shower when she realized something was wrong. She was shampooing her long, red-brown tresses when suddenly, clump after clump tumbled toward the drain. She might have dismissed this as an anomaly—after all, she had given birth to a baby boy six months earlier, and postpartum hair loss, while rare, was nonetheless a possibility—but she had been given a clean bill of health after pregnancy, and had also noticed other problems. She gained 50 pounds; she felt unrelenting fatigue; intercourse became so painful that she recoiled from her husband’s touch; she grew so tired and moody that doctors thought she was depressed or bipolar.
Aside from the baby, K. could think of only one thing that was different in her life: A few months after giving birth, K.’s doctor inserted Mirena, an increasingly popular hormonal intrauterine device that can prevent pregnancy for up to five years. K. demanded her gynecologist remove the device but the doctor couldn’t find it, so she had to have surgery. The Mirena had perforated K.’s uterus and migrated into the abdomen until lodging in her omentum, tissue that protects and connects the internal organs.
Removing the IUD didn’t fix things: Scar tissue related to migration grew, resulting in painful cysts and blocking organs. She has since had four more surgeries to remove scar tissue, including a hysterectomy at the age of 24 that left her infertile. Last week, K. learned she will need another procedure, as the scar tissue keeps returning.
She is one of more than 1,200 women nationwide claiming side effects, including perforation, migration, pelvic inflammatory disease, ectopic pregnancy and, in the most extreme cases like K.’s, painful surgeries and even hysterectomy. Many have filed lawsuits against Bayer, which makes Mirena, and the cases are moving toward class-action status.
And yet K.’s story is exceedingly unusual from a medical standpoint. Approximately 2 million women across the country, and millions more worldwide, use Mirena, and the overwhelming majority have done so for years without incident. The risk of adverse effects like K.’s is approximately one in a thousand, which clinicians, the Food and Drug Administration (FDA) and, of course, Bayer, have agreed is an acceptable rate and comparable to other forms of birth control.
Many plaintiffs’ lawyers aren’t arguing that Mirena is flawed per se; instead, they’re saying Bayer should have done more to warn patients about worst-case-scenario side effects, rather than just mentioning it in the full prescribing information. Bayer rejects that.
“Based on the totality of data available to date, a positive benefit-risk profile continues to be observed with Mirena,” Bayer wrote in a statement to Newsweek. “Bayer has adequately disclosed all known risks associated with Mirena since the FDA first approved it in 2000. Any allegation that Bayer failed to adequately warn of these risks is not based in fact.”
The company’s lawyers recently asked a judge to dismiss many of the cases, claiming they were filed so long after the alleged injuries that they shouldn’t be heard.
The FDA has come down on Bayer for Mirena marketing tactics in one instance, specifically for minimizing risks.
In 2009, Bayer partnered with a social networking site called Mom Central to organize in-home IUD marketing events. A Bayer representative touted the romantic benefits of Mirena at these parties. The FDA said this program violated pharmaceutical marketing regulations, writing in a letter to the company that these claims “misleadingly overstate” Mirena’s efficacy and that the rest of the presentation failed to disclose the product’s risk.
Bayer downplays the Mom Central incident: There were only three gatherings attended by a total of 80 people, and the program was promptly discontinued, the company says.
Many users and medical professionals consider Mirena, along with its chief rival, the copper-containing ParaGard, to be the best birth control available. New York magazine reported that users, who make up 5.6 percent of birth control users today, like these products so much that there’s an “IUD evangelism” trend—women are satisfied to the point where they enthusiastically spread the word about the product to friends, family and, really, anyone who’ll listen.
This is a dramatic shift in public opinion toward the IUD, which first went on sale in the U.S. in the 1960s. Though most of the early IUDs were safe and effective, a flawed model called the Dalkon Shield caused so many pelvic infections, some of which led to hysterectomies and at least 18 deaths, that the makers pulled it from the market in 1974. Lawsuits led to some 200,000 settlements and a $3 billion trust for victims. The bad press toward the Dalkon Shield, while justified, wound up turning women away from all IUDs.
Family planning experts did not abandon the idea behind the IUD, and new models were developed, such as the ParaGard (approved by the FDA in 1984) and, later, Mirena, which have gradually reduced the stigma caused by the Dalkon Shield.
There are several reasons for this.
“The failure rate is somewhere around 0.2 percent, compared to 5 to 7 percent with the pill,” and the side effects are minimal, says Dr. Petra Casey, associate professor of obstetrics and gynecology and director of the Mayo Clinic’s Contraception Practice in Rochester, Minn. “It should be considered a first-line contraceptive.”
The risk of severe side effects with Mirena is about the same as that for oral birth control pills. It’s not a perfect comparison, since the two methods have different kinds of severe side effects. But the most-feared risk with the pill, blood clots, is reported at a rate of approximately 1 to 3 women per 1,000, which, again, is around that of Mirena.
Dr. Anne Burke, an assistant professor of gynecology and obstetrics at the Johns Hopkins University School of Medicine, speaking on IUDs generally and not the litigation, says, “The overwhelming amount of data indicate that while these complications can happen, fortunately they’re rare. Most the women who use this device are able to use it safely.”
Women’s health experts also attest to noncontraceptive benefits of Mirena, such as Dr. Lynne Bartholomew Goltra, an ob-gyn at Massachusetts General Hospital.
“In addition to making women’s periods lighter and less painful, it may lessen the pain from endometriosis and may prevent some pelvic infections [pelvic inflammatory disease],” Goltra says. “It has been used to prevent the development of precancerous endometrial hyperplasia in women at higher risk of developing this and is effective in treating some types of this condition.”
Women’s health professionals have encouraged greater use of IUDs because they are more reliable than other methods and therefore prevent many more unintended pregnancies. Pregnancy is in itself a condition that carries risk, with complications ranging from ectopic pregnancy to pre-eclampsia, diabetes and urinary tract infections. Unintended pregnancies can be even more risky if the mother has not taken precautions such as giving up smoking and alcohol. Among developed countries, the United States has among the highest rates of unintended pregnancies: 51 percent of the 6.6 million pregnancies nationwide.
The lawyers involved with the cases argue that Mirena’s success with most woman doesn’t mean much to the the minority who have suffered.
Carmen Scott, who leads pharmaceutical litigation with Mount Pleasant, S.C.–based Motley Rice and has worked on many reproductive health cases, says that the device’s negative impact is apparent in the hundreds of women represented by her firm.
“Many of the women that this product is prescribed to are very young and plan on having families,” Scott, who’s arguing many of these Mirena cases, says.
“This device has prevented that in many young women.”
Bayer, which does indicate that perforation can happen upon insertion, needs to make clearer that perforation can take place long after the IUD is implanted, says James Ronca, an attorney at the Philadelphia-based firm Anapol Schwartz who represents many Mirena plaintiffs.
“If 500 people were on a 747 and it crashed or there were some other incident where a lot of people were injured, planes would be grounded and there would be an investigation,” Ronca says.
By extension, the 2,000 people expected to sue Bayer is not “an insignificant number” and worth an additional warning, he says.
In this complicated case, however, it’s not just Bayer whose marketing tactics have been called into question. Some of the lawyers representing plaintiffs have drawn ire for their ads from legal reformers and physicians. Many women who complain about Mirena learn of litigation via prominently displayed search engine ads or social media.
Dr. Nancy L. Stanwood, a member of the American College of Obstetricians and Gynecologists’ work group on long-term contraceptives, said that Mirena lawsuit commercials airing in her area have “scared off” women who would greatly benefit from the device.
“It’s clear that those commercials are designed to be scary and to not put the medical facts in appropriate context,” she says, which “is unfortunate and a disservice to women having a full and accurate understanding of what their contraceptive options are.”