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IUDs Are Back and So Are the Adverse Reactions

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Southlake, TXAlong with the skyrocketing use of intrauterine devices (or IUDs) come new concerns about the potential health risks of the device. More than 47,000 adverse reactions associated with the use of a Bayer Healthcare Pharmaceuticals Mirena intrauterine device (IUD) were reported to the FDA between 1997 and 2013. The top three problems, according to the FDA report, were “device expulsion, device dislocation and vaginal hemorrhage.”

“We have interviewed and gathered medical records on many women,” says Dr. Shezad Malik from his office in Texas. “They have a wide range of injuries including perforation of the uterus. We have also seen women who were using the Mirena IUD who had to have a hysterectomy to remove their uterus because it was so badly damaged and could not be repaired. Their child-bearing years are sadly at an end.”

The IUD fell out of fashion in the 70s and 80s, and was destined for the history books after the Dalkon Shield and the Copper 7 IUDs become associated with perforated uteruses, ectopic pregnancies and other injuries associated with their use.

“Those IUDs caused a lot of problems,” says Dr. Malik, who is both a physician and an attorney, “and here, after many years, is another intrauterine device and women are again reporting problems.”

In 1995, it was estimated that only .08 percent of American women were using IUDs, but by 2010, that number had increased seven times to 5.6 percent, according to an October 18, 2012 study by the Guttmacher Institute, and reported in the National Survey of Family Growth.

The FDA approved Bayer’s Mirena IUD for use in the US in 2000. It is a small, white T-Shaped plastic device with a levongorgestrel hormone slow-release system attached. Bayer recommended it as an excellent choice for women who had had at least one child but wanted to interrupt child bearing for several years. Bayer claimed its Mirena IUD was safe and effective for five years.

“The big selling point was that this was an ‘insert and forget’ type of birth control,” says Dr. Malik. “The problem is that women have ended up with a lot of injuries. Had women been aware of the potential for damage I don’t believe many women would have opted to use this device.”

“There are many things that can go wrong,” Dr. Malik points out. “The IUD is made of plastic and can cause perforation of the uterus; it can embed in the thin muscle wall of the uterus, and can even migrate into the abdominal cavity and perforate other vital organs such as the intestines, blood vessels, the stomach and the liver.”

“The estimated incidence of these kinds of complications is 1 in 1000, and that is very high,” says Dr. Malik.

In 2009, the FDA wrote to Bayer saying that it had essentially failed to properly research Mirena side effects before marketing the IUD as a safe and effective form of birth control. The letter said “Bayer overstated the efficacy of Mirena, presented unsubstantiated claims and minimized the risks of using Mirena.”

A number of lawsuits are underway in the US against Bayer and the Mirena IUD. The suits allege failure to warn patients of potential side effects, stated proffered complications were “uncommon,” designed and produced a defective product, and engaged in deceptive marketing.

“The oral contraceptive is so easy to take rather than going to a doctor and having this inserted. You are essentially introducing a foreign body into that uterus and there are much safer methods of birth control,” says Dr. Malik.

The Dr. Shezad Malik Law Firm has offices in both Southlake and Fort Worth, Texas. Dr. Malik is a board-certified internist and cardiologist, and an attorney. Lawyers at the firm handle a variety of personal injury, litigation and mass tort cases, and have extensive experience in the areas of medical malpractice, wrongful death, tractor trailer and commercial vehicle accidents, product liability, brain, burn, electrical and spinal cord injuries, and other types of catastrophic injuries.


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