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Paragard Marketing Campaigns Avoid the Most Important Data-Its Dangers

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Since it was first approved by the FDA in 1984 and available to US consumers in 1988, the manufacturers of the contraceptive Paragard have boasted about its effectiveness as a contraceptive medical device as well as being 100% hormone free. Paragard’s popularity has grown in the ensuing decades commensurate with its approval for longer implantation. In 1984, it was approved for four years. In 1989, that number grew to six years. In 1991, it was approved for 8 years. Finally, in 1994 Paragard was approved for continuous use up to 10 years.

However, there have been issues associated with the copper IUD. The copper arm of the medical device can break and embed itself in the uterus. Contrary to what the manufacturers indicate this is not an uncommon occurrence. The FDA has received more than 1,600 reports of Paragard plastic arm breakage since 2010. A 2014 MedSun report indicated that both arms of the Paragard system were missing when doctors attempted to remove the device 6.5 years after it was placed. A sonogram indicated that the arms of the device had become embedded in the woman’s uterine tissue.

The arm of the IUD may break during explant or it may break due to a design defect in the copper requiring surgical removal.

Once the copper IUD breaks, surgical intervention may be required in the form of a hysteroscopy, laparoscopy, laparotomy, or hysterectomy. These surgical procedures come with their own set of dangers and consequences.

According to Drug Watch, “The current prescribing information provided by Cooper Surgical lists “device breakage” under the postmarketing adverse events section but doesn’t say how often it occurs. It does warn that “breakage of an embedded Paragard during non-surgical removal has been reported.”

Under the instructions for healthcare providers on how to remove the Paragard, it reads: “The threads can retract into the uterus or break, or Paragard can break, perforate the uterus, or be expelled.”

In addition, it cautions healthcare providers that, “Breakage or embedment of Paragard in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or other grasping instrument, or hysteroscopy may assist in removing an embedded Paragard.”

If you or a loved one have suffered after the implantation of Paragard, contact us today for a free, initial consultation. 

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