CLEVELAND - An investigation has uncovered concerns about the safety of a popular form of birth control.
There are currently two million women using the Mirena intrauterine device (IUD).
WEWS, our Scripps station in Cleveland, obtained complaint records from the Food and Drug Administration that indicated there have been 70,072 complaints about the Mirena IUD since 2000.
Read about the complaints here: http://bit.ly/139Va6U
Many complaints involve serious complications. Since 2008, 4,775 women reported "device dislocation." This may refer to the IUD becoming embedded in the uterus, moving from its initial placement at the top of the uterine cavity, or an IUD that has migrated outside the uterus, an FDA spokesperson said.
The complaint reports also show 1,322 women have reported uterine perforations since 2008.
"I started getting severe pain," said Sara, a mother of three who got a Mirena IUD three years ago.
The pain eventually became so severe she went to the emergency room.
"They did an X-ray and saw that the IUD has completely perforated through my uterine wall and was just floating around in my abdomen," she said.
Doctors had to perform surgery to remove the IUD.
"It was horrible. I would never recommend it to anyone," said Sara.
There are at least 100 lawsuits currently filed in New Jersey against Bayer Healthcare Pharmaceuticals, the company that manufactures Mirena.
There are also currently 50 lawsuits filed in federal court against Bayer.
Ohio attorneys John Climaco and Dawn Chmielewski filed five of the federal lawsuits, but said they are reviewing several hundred more cases.
"It says to me that there's a problem with this device," said Chmielewski, adding that Bayer failed to properly warn physicians and patients about the risks.
"What these people aren't being told is that at any time after this device is in place, it can perforate the uterus and cause these complications," she said.
Chmielewski said the injuries from complications can be "horrific," and that one client's IUD lacerated her liver.
Another client had an appendectomy, hysterectomy and stomach tissue removed after her IUD became embedded in her uterus.
Another court case involves the Mirena IUD migrating into a woman's rib cage.
"The only way they know to get it out is to perform a sternotomy, which is to actually break open her sternum, the same type of procedure you have during open heart surgery," Chmielewski said.
"I think it's really a crying shame. I think that if you polled physicians, we just don't have that opinion, that this is a defective product," said Dr. Thomas Frank, the director of Family Planning at MetroHealth Medical Center.
Dr. Frank has prescribed the IUD to patients since 2001.
"Medical evidence is quite clear that Mirena IUD is one of the absolute safest forms of contraception that's available today,” he said. "Mirena is really appropriate for any woman who is potentially fertile who doesn't want to get pregnant."
"It's amazing. It's so convenient," said Ally Thompson, who uses Mirena. "You don't have to worry about taking a pill every day, and it lasts for five years, so you can't beat that."
Bayer declined an opportunity for an on-camera interview. The company sent this statement to WEWS:
"At Bayer, we care about patients and take the safety of our products very seriously. For that reason, we continuously review the safety profile of all of our products worldwide. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause.
"Although we are unable to comment on specific lawsuits, Bayer continues to stand behind Mirena as an important option for women who have had a child and are seeking a safe and effective contraception option. Based on the totality of data available to Bayer since the launch of Mirena in 2002, a positive benefit-risk profile continues to be observed and is fully aligned with what was seen during the clinical development program that formed the basis for the product’s approval worldwide."
The FDA sent WEWS this statement:
"It's important to note that all drugs have side effects; no drug is absolutely safe. FDA-approved drugs have demonstrated that their benefits outweigh their known risks. The agency continuously monitors all approved drugs for new safety concerns, and we update the drug labeling or take regulatory action as appropriate.
Mirena's benefits and risks are outlined in the drug labeling, including the risks of embedment in the myometrium and perforation of the uterine wall or cervix. There are currently many FDA-approved birth control methods available. Women should discuss with their doctor the most appropriate birth control method for them."
"The overall risks of the Mirena IUD are tremendously less
than the risk of the other devices that are available today and much less than the risk of not using any protection at all," said Dr. Frank.
Sara was able to give birth to a healthy baby boy after her Mirena IUD was removed, but she still has pain on her left side. Her doctor told her it is nerve damage that will never go away.