Women Injured During ParaGard Removal May Have Lawsuit Claims

March 24, 2017, 6:00PM. By Deb Hipp

Dallas, TXWomen who had the ParaGard IUD contraceptive device inserted and then suffered injuries from the removal process may have grounds for a lawsuit against the medical device manufacturer.

"Women who have had this device inserted should be aware that when it comes time for it to be removed, risk of break-up may lead to injuries," says attorney Dr. Shezad Malik, who is also a medical doctor. "If that happens, those patients may have a claim for damages."

TEVA Pharmaceuticals manufactures ParaGard, a T-shaped, copper-releasing intrauterine contraceptive device approved by the Food and Drug Administration (FDA) in 1984.

ParaGard is a non-hormonal IUD, which makes it an alternative to hormonal IUD brands such as Mirena, Skyla or Liletta. The copper released by ParaGard acts as a spermicide, producing an inflammatory reaction in the uterus that is toxic to sperm, which helps prevent fertilization.

The ParaGard IUD is approved as being effective for up to ten years. However, when that ten years expires and a health care professional attempts to remove ParaGard, complications may occur.

"Occasionally, ParaGard may be hard to remove because it is stuck in the uterus," according to ParaGard's patient instructions. "Surgery may sometimes be needed to remove ParaGard."

"If someone develops injuries due to break-up during the removal process, they may have a claim," says Dr. Malik. Women coming to the end of their ten-year ParaGard IUD cycle may notice that they've been injured, he says.

On record with the FDA is a 2015 Medsun report of a woman who had the ParaGard IUD inserted and upon removal, eight and a half years later, the copper coil was found to be missing from the long portion of the IUD. "Copper was present on "T" arms of device and both arms were intact," according to the report.

"If a device is defective and breaks up, any injuries that occur from the allegedly defective device entitle the injured person to compensation," says Dr. Malik.

Potential adverse reactions to ParaGard include embedment, perforation, pelvic infection, ectopic pregnancy, septic abortion and intrauterine pregnancy, according to ParaGard's patient instructions pamphlet.

A woman may have a claim if she had to have a hysterectomy due to ParaGard injuries or if the device or fragments migrated, puncturing the colon for instance. Malik says, "It would have to be something that requires invasive surgical intervention.

"Time is of the essence when it comes to a person filing a personal injury lawsuit for ParaGard IUD injuries," says Dr. Malik, since most states have a two-year statute of limitations on personal injury claims. "They want to file a claim before time runs out."

Dr. Malik represents individuals in personal injury cases through his law office, The Dr. Shezad Malik Law Firm, in Dallas, TX.