FAQs About a Recall on the ParaGard IUD

46
ParaGard IUD

Though it has been around for decades, there seems to be a growing call to recall the ParaGard IUD. Here are some FAQs about this common birth control method.

What is the ParaGard IUD?

The Paragard IUD (also known as TCu380A, or Jaydess in Europe) is a long-acting, reversible form of birth control that’s been around since the 1970s. In fact, the Paragard IUD was the first copper IUD approved in the US.

How Does the ParaGardWork?

The Paragard IUD (also known as TCu380A, or Jaydess in Europe) is a long-acting, reversible form of birth control that’s been around since the 1970s. In fact, the Paragard was the first copper IUD approved in the U.S.

A non-hormonal form of birth control, the ParaGard can remain in place for up to twelve years. It is a form of long-acting contraception, which means it’s intended to be left inside the uterus for 5 years. The unique thing about it is that it works not by preventing fertilization but by preventing implantation.

Who Makes this Non-hormonal IUD?

The Paragard IUD is made by an international company called Teva Pharmaceuticals. Its headquarters are in Petah Tikva, Israel, and it is the largest generic drug manufacturer in the world. A privately-owned company, it is not listed on any stock exchange and does not publish interim results.

Teva is the largest generic pharmaceutical company in the world and makes both branded products (a few of which they own) and generic drugs. They are headquartered in Petach Tikvah, Israel.

Have There Been Lawsuits Regarding ParaGard?

There have been thousands of ParaGard lawsuits filed over the contraceptive device with its manufacturer, Teva Pharmaceuticals. Some of those claim that rather than releasing the IUD from the uterus upon removal, as it is designed to do, it sometimes perforates the uterus, causing internal injuries that require surgery to repair.

Judges on the United States Panel on Multi-district Litigation issued a transfer order in December 2020 that centralized cases from courts across the nation in the Northern District of Georgia. At this time there are at least 80 cases pending, with hundreds more expected.

Defendants consist of Teva Pharmaceuticals USA, Inc., Teva Branded Pharmaceutical Products R&D, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, CooperSurgical, Inc., and The Cooper Companies,Inc.

What Legal Complaints Have Been Made Concerning the ParaGard?

A complaint filed in North Carolina states:

“On September 14, 2014, American Civil Liberties Union (ACLU) attorney Alexa Kolbi-Molinas filed a class action lawsuit against the Paragard® IUD manufacturer and generic manufacturers of the Paragard® device. The complaint is on behalf of female patients who have suffered body tissue damage as a result of a broken Paragard® device being pushed through her cervix during removal.”

The complaint alleges that Paragard’s label is false and misleading in that it fails to properly disclose both the nature of this risk and the very real possibility of perforation upon removal.

According to the complaint filed by Heather Lynde in the U.S. District Court of North Carolina, the Paragard IUD label should have included a black box warning regarding this unlabeled risk, as well as specific warnings about using the device only in accordance with accepted medical practice. Lynde points out that her physician violated such standards when he failed to cut or otherwise weaken the arms of the device before attempting removal.

What Side Effects are Associated with the ParaGard?

Potentially common side effects include:

  • Backache
  • Anemia
  • Cramping
  • Dyspareunia (painful sexual intercourse)
  • Dysmenorrhea (painful periods)
  • Longer than normal periods
  • Spotting in between periods
  • Expulsion (complete or partial)
  • Pain
  • Vaginitis

Serious Side Effects

While more rare, serious side effects with Paragard can occur. These include:

  • Pelvic inflammatory disease
  • Ectopic pregnancy (pregnancy outside the uterus)
  • A severe infection called sepsis
  • Perforation or embedment in the uterus.
  • Breakage when removed

It is this last serious side effect that prompted the class action suit against Teva Pharmaceuticals. According to Lynde’s complaint: “[defendants knowingly, purposely and deliberately failed to adequately warn Plaintiff, patients, consumers, medical provider, and the public of the increased risk of serious injury associated with using the Paragard IUD.”

Has the ParaGard Been Recalled?

The short answer is no but that may change soon.

Plaintiffs filed a motion on Dec 2020 to transfer all Paragard federal litigation to be centralized in the U.S. District Court for the Central District of California in order to avoid differing pretrial rulings from various courts, circumvent duplicative discovery, and “serve the convenience of common witnesses, parties and the judicial system.”

It isn’t unusual for the federal court system to centralize litigation for pretrial proceedings. But, if Paragard settlements have not been reached during discovery or in early “bellwether” trials, individual claims may be remanded back to the U.S. District Court where it was initially filed where they will go before a jury.

Conclusions

It is widely known that the Paragard birth control intrauterine device is not just causing infections but is also releasing toxic metals into the bloodstream of women using it. The device is currently under multiple class-action lawsuits with no current recall process in place.

Any Ideas / Suggestions About This Topic

LEAVE A REPLY

Please enter your comment!
Please enter your name here