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I-Team: Birth Control Device Causing Serious Injuries

By Karen Anderson, WBZ-TV
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BOSTON (CBS) – Women have a lot more birth control options today than they did 20 years ago; some even reduce the symptoms and duration of a woman’s period. One form of birth control is growing in popularity because for many women it eliminates their period altogether. But as the I-Team discovered, while some women enjoy the convenience, others are living a nightmare.

Six-year-old Lola and five-year-old Kelvin were supposed to be part of a bigger family. “When we got married, we planned to have five,” explained their mother, Galina, who doesn’t want us to use her last name.

Galina is now afraid that her body can’t handle another pregnancy after her birth control went terribly wrong. She had the Mirena IUD inserted into her uterus shortly after Kelvin was born.

The Mirena is a small, flexible plastic, t-shaped device that slowly releases hormones. It creates an environment in the uterus that is not conducive to conception. When a woman wants to have a baby, it can be simply removed by pulling on the strings attached to the bottom of the device.

For Galina, it wasn’t so simple. She had constant pain. When she stopped nursing Kelvin, she began having two periods a month, which was opposite of what doctors told her would happen. “I actually thought that maybe I have cancer,” she said.

When she went to the doctor, they didn’t find cancer, or the Mirena. “It was outside of my uterus,” Galina explained. X-ray images show the device perforated her uterus and was loose in her abdomen. She had to have surgery to remove the device.

Mike Doyle is an attorney representing Galina and several other women as part of two larger suits that involve more than 300 victims. “The worst cases you actually had women who lost their uterus and had to have a hysterectomy,” he said.

Erin Brockovich, a consumer advocate who was the subject of a movie starring Julia Roberts, has a website dedicated to warning women about the risks of this device. “Let’s not use this product until we figure out what the hell is going on,” she said. “Right now, Mirena IUD is certainly presenting a lot of havoc in a lot of women’s lives,” she added.

The I-Team has learned that initial safety tests on Mirena did not include women who were nursing, like Galina. Back in August, the FDA approved a label change. It now reads: Risk of uterine perforation is increased when Mirena is inserted in lactating women.

When the I-Team contacted Bayer Pharmaceuticals, the manufacturer of Mirena, a spokesperson sent this statement. “Bayer stands behind Mirena as an important option for women who have had a child and are seeking a safe and effective contraception option.”

But the I-Team discovered some doctors in the Boston area say Mirena is OK for women who have not had children. One local practice even states on its website that Mirena is fine for teens.

Dr. Brigid McCue, an OB/GYN at Jordan Hospital said patients need to remember there are risks to everything and that perforation with the Mirena is very rare. She said the device is a great option for thousands of women. “Once you have it placed and you are comfortable with it, you can have five years of peace,” she said.

A spokesperson for the FDA says the agency is monitoring all reports of adverse effects, but for now the agency believes the benefits of Mirena outweigh the risks.

MORE HEALTH NEWS FROM CBS BOSTON

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