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MIRENA

Monday, April 28, 2014

The Courtroom Controversy Behind Popular Contraceptive Mirena

The Courtroom Controversy Behind Popular Contraceptive Mirena

By Victoria Bekiempis / April 24, 2014 1:04 PM EDT  

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.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.”


Thursday, September 5, 2013

LEARN ABOUT THE SIDE EFFECTS OF MIRENA

Mirena IUD Side Effects

Mirena is an intrauterine device (IUD) that is inserted into the uterus to prevent pregnancy. It is a hormonal birth control method that involves the release of progestin in order to suppress ovulation, thin the uterine lining, and prevent fertilization of an egg. Mirena is intended to offer long-term pregnancy prevention, and women may have the device in for up to five years before a replacement is needed. However, many serious Mirena side effects have been reported to the FDA. About 45,000 adverse events have already been reported.

Common Mirena IUD side effects

Possible side effects of Mirena IUD birth control can include:

  • Yellowing of the skin and eyes
  • Pain during intercourse
  • Infection (fever, chills)
  • Allergic reaction (trouble breathing, swelling of the facial region, hives)
  • Pale skin/easy bruising
  • Weakness
  • Extreme dizziness
  • Pelvic pain and cramps
  • Vaginal bleeding, sores, or discharge
  • Abscess
  • Embedment in the uterine wall
  • Erosion of the IUD

Some women have also experienced Mirena side effects like back pain, mood changes, weight gain, nausea, vomiting, and bloating. It’s also possible to experience heavy menstrual bleeding or breakthrough bleeding, along with other irregularities in menstruation.

Mirena can also cause ovarian cysts, which are abnormal growths of the ovaries that can rupture. If this complication occurs, internal bleeding and ovarian torsion may result.

IUD migration may lead to perforation of the uterus

                        The Mirena IUD is inserted by a healthcare professional, and it is intended to remain in place until the healthcare professional removes it. However, the uterine wall can be perforated, or punctured, by the IUD when the doctor inserts it. In addition, the FDA has received many reports of perforation that occurred at some point after insertion. This adverse event can lead to infection, organ damage, and adhesions.

Uterine perforation often requires surgery, and sometimes multiple surgeries may be needed. Scar tissue that develops as a result of surgery may cause infertility. Women who have experienced these Mirena IUD side effects have reported heart palpitations, nausea, vomiting, fever, and abdominal pain.

Migration of Mirena necessitates surgery

It’s critical for Mirena patients to see their healthcare providers upon experiencing any possible symptoms of uterine perforation. If treatment is delayed, the device can migrate further until it is outside the uterine cavity. This risk is heightened in women who have this birth control device inserted shortly after giving birth, particularly while they are breastfeeding.

Some women have suffered from intestinal perforation due to migration of the Mirena device. This can lead to abscesses, intestinal obstruction, and damage to other organs and tissues, along with adhesions and scarring. Patients might require surgical intervention to remove the IUD once it has migrated, and surgeries carry additional risks, such as adverse reactions to anesthesia and infections.

Pelvic inflammatory disease (PID) reported

Mirena side effects can also include pelvic inflammatory disease, which is a bacterial infection. Severe indications of PID include symptoms of shock, including fainting, as well as a high fever, vomiting, and severe lower abdominal pain. Some women may also have difficulty passing urine, fatigue, and a heavy, foul-smelling vaginal discharge. If it is left untreated, PID can lead to chronic pelvic pain, infertility, and an ectopic pregnancy.

If an ectopic pregnancy occurs, it is a potentially life-threatening situation that requires prompt medical care to remedy significant internal bleeding. It occurs when a fertilized egg is unable to travel through the fallopian tube. Emergency surgery is required to treat it.

More women using IUDs

It has been estimated that 15 million women worldwide have used the Mirena IUD, with 2 million women in the U.S. relying on the birth control device manufactured by Bayer. Positive reviews have noted the convenience of the device; unlike a pill, it does not need to be taken daily. Clinical trials have shown Mirena to be more effective in stopping pregnancy than oral contraceptives: the failure rate with Mirena, when working correctly, is less than 1% over five years.

In 2002, about 1.4 percent of contraceptives used were IUDs, whereas in 2010, IUDs made up about 10.4 percent of prescribed birth control.

Mirena FDA warnings

The FDA approved Mirena for consumer use in 2000. However, in 2009, the a Mirena FDA warning to Bayer, the manufacturer. The FDA noted a misbranding of the product, and stated that the company made misleading claims regarding its indications. Bayer had launched a marketing campaign that insinuated that the Mirena IUD would improve a couple’s intimacy and romance.

In that same warning letter, the FDA noted the potential for serious Mirena IUD side effects. The warning letter stated that Bayer had failed to adequately warn consumers of the side effects of the IUD, and that the company did not make accurate statements regarding the proper functioning of the device.

Mirena side effects prompt lawsuits

These potentially permanent complications have prompted many to file Mirena lawsuits against Bayer. Many of the lawsuits claim that the company failed to warn doctors and patients of the risks of the IUD device. Mirena lawyers for the plaintiffs have often cited migration of the device and the potential for uterine perforation as injuries for which Bayer is liable. Lawsuits allege that the company has claimed that these side effects are not common.


Monday, June 3, 2013

MIRENA IUD LAWSUITS HEAT UP

As Mirena lawsuits continue to move forward in both state and federal courts, attorneys note that a new Mirena side effects study has found that the bleeding and spotting that sometimes occurs in the months after insertion of the levonorgestrel-releasing IUD (sold under the brand name Mirena) could not be relieved with medication. The study, published online April 5 in Obstetrics & Gynecology, was designed to identify a 25% reduction in the number of bleeding or spotting days for the first 3 months following insertion of the IUD. However, the study found that the administration of one of two drugs commonly used to treat heavy menstrual bleeding and menstrual pain only reduced the number of bleeding days by six and three, respectively.

This study is just another reminder of the Mirena side effects that can occur in women who use this IUD. In addition to the bleeding described in this report, numerous women who allegedly suffered more serious complications, including organ damage, infections and other problems associated with the spontaneous migration of a Mirena IUD

The Foulston Law Firm currently offers free legal evaluations to women who suffered serious Mirena side effects, including uterine perforations, stemming from the migration of Mirena.

Mirena IUD Lawsuits
The Mirena IUD was approved by the U.S. Food & Drug Administration (FDA) for contraception in 2000, and in 2009, for the treatment of heavy menstrual bleeding in women who wish to use an IUD as their method of birth control. The small, plastic t-shaped device is inserted into the uterus by a healthcare provider, where it may remain for up to 5 years, releasing a low-dose of the synthetic progestin, levonorgestrel. Since coming on the market, statistics from the FDA indicate that Mirena side effects have been cited in thousands of adverse event reports made to the agency. Device migration was the second most-common Mirena complication reported to the FDA.

According to a Transfer Order dated April 8th, the U.S. Judicial Panel on Multidistrict Litigation has transferred all federally-filed Mirena lawsuits to U.S. District Court, Southern District of New York for pretrial proceedings. According to the Order, more than 40 Mirena IUD lawsuits have been filed in 17 federal jurisdictions, all of which allege Mirena migrated away from its original position in the uterus, leading to uterine perforations and other serious Mirena side effects. Plaintiffs further allege Bayer Healthcare Pharmaceuticals failed to provide adequate warnings regarding the risk of device migration and related side effects. (In re: Mirena IUD Products Liability Litigation, MDL No. 2434 (JPML)

Court documents also indicate that at least 47 Mirena lawsuits are pending in New Jersey Superior Court. In August 2012, Bayer filed an application with the New Jersey Supreme Court seeking the establishment of a consolidated litigation for all Mirena IUD lawsuits filed in the state in Middlesex County. While the request was rejected, plaintiffs in in those claims recently filed a new application with the Court asking it to reconsider. ****

Alleged victims of Mirena side effects caused by spontaneous migration of the IUD may be entitled to file their own Mirena lawsuit seeking compensation for medical expenses, lost wages, pain and suffering, and more.

Contact the Foulston Law Office for more information on this topic.

 


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