Paragard IUD Lawsuits - Consumer Justice Foundation

Paragard IUD Lawsuits

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Patients who received a Paragard birth control implant are hiring Paragard IUD lawyers to pursue lawsuits against Teva Pharmaceuticals and Cooper Companies Inc., alleging that the intrauterine device is prone to breakage during removal and puts users at risk for severe and potentially life-threatening injuries.  

Hormone-free intrauterine devices (IUDs) like Paragard are a popular alternative to traditional hormonal birth control methods. However, these medical devices have also been linked to adverse side effects and complications. For instance, Paragard must be implanted and removed by a medical professional and pieces of the device can break off or fracture after the device is implanted or during the removal process, which can be painful and dangerous and may require additional surgery or possibly even a hysterectomy. Women have also reported problems stemming from the body’s reaction to the copper in the birth control device and problems with the IUD itself that may result in devastating injuries. Dozens of Paragard IUD lawsuits currently pending against Teva and Cooper allege that the companies failed to warn about the possibility of the copper birth control product causing serious complications requiring removal of the device and/or fracturing or breaking during removal. If you or someone you love has suffered a serious injury that you believe is related to a Paragard copper IUD, you may be eligible for a Paragard IUD injury lawsuit. Contact our consumer advocates at the Consumer Justice Foundation today to explore your possible compensation options.

Paragard IUD Alternatives for Pregnancy Prevention

Paragard is the only copper IUD currently available in the United States, and many women have chosen Paragard over other methods of contraception based on the fact that the IUD contains no hormones. The potential side effects of hormone-based birth control products are well-documented, but the Paragard IUD carries its own potential health risks. If you are looking for a hormone-free method of birth control and you want to avoid the serious side effects that have been linked to the Paragard copper IUD, you may want to consider the following alternative methods of contraception:

  • Natural family planning (fertility awareness)
  • Female and/or male sterilization
  • Barrier methods (condoms, diaphragms, cervical caps and sponges)
  • Rhythm method (abstaining from sex on fertile days)
  • Withdrawal method
  • Basal body temperature method
  • Standard Days Method
  • Cervical mucus method
  • Herbal birth control

What is the Paragard IUD?

Paragard is a T-shaped copper intrauterine device designed to provide women who want to avoid getting pregnant with a hormone-free, long-term form of reversible birth control. Paragard was originally approved by the FDA in 1984 and since 1994, the IUD has been approved for up to 10 years of use. Originally manufactured by Teva Pharmaceuticals before being acquired by Cooper Companies in 2017, the Paragard IUD is marketed as a safe and effective birth control method meant to provide continuous pregnancy prevention for up to 10 years. The IUD is made of soft, flexible plastic with a thin layer of copper around the arms and stem. Once implanted, the copper component in the birth control device creates an inflammatory reaction in the uterus, which interferes with the process of conception and prevents fertilization.

Potential Side Effects Resulting in a Paragard IUD Lawsuit

Women implanted with a Paragard IUD run the risk of potentially experiencing serious complications that may occur after implantation or during the removal process. The following are some side effects that have been linked to use of the Paragard IUD for pregnancy prevention:

  • Device breakage or fracture
  • Allergic reaction to the copper IUD
  • Chronic pain
  • Inflammation
  • Irregular bleeding
  • Cramping
  • Infection
  • Perforation of the uterus
  • Unintentional pregnancy
  • Pelvic inflammatory disease
  • Ectopic pregnancy
  • Expulsion of the IUD from the uterus
  • Migration of the IUD to other parts of the body
  • Hysterectomy
  • Scarring and damage to internal organs
  • Infertility
  • Wrongful death

Link Between Paragard IUD and Side Effects

The Paragard website claims that the copper contraceptive device is more effective than any other hormone-free birth control method – and most hormonal methods. The website also claims that the IUD can be removed at any time. However, over the past several decades, a growing number of consumer complaints and scientific studies have indicated that the Paragard IUD can fracture or break during the removal process or at any time after implantation, which may result in the need for additional surgeries to retrieve the broken pieces of the IUD, possibly including a hysterectomy. Other potential plaintiffs in the ongoing Paragard IUD litigation include patients who suffered allergic reactions from the copper in the IUD or those who experienced other serious side effects caused by the IUD becoming embedded in the uterine wall or migrating out of position.

Since the Paragard IUD first entered the market in the U.S., the FDA has received more than 37,000 reports of adverse events associated with the birth control implant and nearly half of these adverse event reports were classified as “serious,” including 15 patient deaths. In 2019 alone, 7,265 adverse events were reported to the FDA in connection with the copper IUD implant. And while the makers of Paragard claim that “your ability to get pregnant will return immediately” after you remove the device, some women have experienced infertility due to alleged Paragard IUD side effects.

Lawsuits Against Paragard IUD for Device Fracture, Expulsion, Other Complications

June 2016 – A Paragard IUD lawsuit filed in federal court claims that the birth control device fractured during removal and embedded in a Nebraska woman’s uterus, requiring surgery to remove the IUD.

October 2018 – A California woman implanted with a Paragard IUD says she suffered permanent damage to her reproductive organs when a piece of the birth control device broke off inside her uterus.

May 2020 – A Paragard IUD lawsuit is filed in Southern Illinois, alleging that Teva Pharmaceuticals knew the copper birth control device was “dangerous and unreasonably defective” and deliberately withheld safety information from patients and healthcare providers.

August 2020 – A New York woman files a Paragard IUD lawsuit against Teva Pharmaceuticals and Cooper Companies Inc. in federal court, alleging that a piece of her birth control implant broke off while the IUD was being removed.

September 2020 – A Paragard IUD lawsuit is filed in Florida by a plaintiff who states that she had a copper IUD in place for 10 years before having it removed by a healthcare provider. When the device was removed in 2018, one of the arms was missing and remained in her uterus.

September 2020 – A motion is filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking consolidation of all Paragard IUD lawsuits before one judge for coordinated pretrial proceedings.

September 2020 – A Paragard IUD lawsuit filed in Missouri alleges that the plaintiff experienced devastating injuries when her birth control device fractured inside her uterus during the removal process.

September 2020 – A South Carolina woman seeks compensation from the makers of the Paragard IUD for injuries she allegedly sustained when her birth control implant migrated out of position and then, upon removal, broke apart inside her body. According to the complaint, a surgeon attempted to retrieve the broken fragments of the Paragard IUD, but was unsuccessful.

October 2020 – A product liability lawsuit filed in New York alleges that the Paragard IUD, which allegedly fractured and became embedded in the plaintiff’s uterus, is defectively designed and prone to breakage during removal.

October 2020 – The makers of the Paragard IUD face a product liability lawsuit filed by an Indiana woman who claims that the potential side effects of the copper intrauterine device were not properly disclosed to users or healthcare professionals.

October 2020 – A Missouri woman seeks compensation from the makers of the Paragard IUD for the severe internal injuries she allegedly suffered when doctors attempted to remove the birth control device. According to the complaint, a piece of the IUD broke off in the plaintiff’s cervical canal and had to be removed via hysteroscope.

November 2020 – A Minnesota woman files a product liability lawsuit against the makers of the Paragard IUD, alleging that the birth control device fractured when her doctor attempted to retrieve it, leaving her with permanent internal injuries.

FDA and Paragard IUD

July 2014 – A report submitted to the FDA’s Medical Product Safety Network describes a patient who went to a clinic to seek removal of her Paragard IUD, which had been in place for 6.5 years. When the device was removed, it was missing both arms. A sonogram showed that both arms were embedded in the uterine tissue and a hysteroscopy was required to remove the broken fragments.

July 2014 – A hospital reports four cases where Paragard IUD devices fractured during removal. According to the FDA report, three of the four devices were well under their expected lifespan. The report also notes that “Hospital’s incidents represent a large increase in reporting for this device.”

January 2015 – A woman has her Paragard IUD removed due to cramping. Upon removal, it is discovered that both of the implant’s arms are missing.

January 2015 – A Paragard IUD removed from a patient’s body has the copper coils intact on the arms of the IUD, but the copper coil is missing from the IUD stem.

February 2015 – A report submitted to the FDA’s Medical Product Safety Network details a case in which a Paragard IUD removed from a patient’s uterus after 8.5 years is missing the copper coil from the stem of the device.

July 2019 – The FDA sends a cease-and-desist letter to CooperSurgical, a unit of Cooper Companies, regarding a Paragard IUD television ad, which the agency says “makes false or misleading representations about the risks associated with ParaGard.”

September 2020 – According to the FDA’s Adverse Event Reporting System (FAERS) database, there have been a total of 37,389 adverse events reported in connection with the Paragard IUD, including 15,754 “serious” cases and 15 deaths.

Paragard IUD Side Effect Studies

February 2006 – A randomized controlled trial published in the journal Human Reproduction indicates that about 10% to 13% of IUD users will have their IUD removed because of bleeding during the first year of use.

February 2007 – A review of published articles comparing IUD performance among parous women (women who have given birth) versus nulliparous women (women who have never given birth) using copper IUDs finds that nulliparous women had higher rates of expulsion and removals due to pain and bleeding.

May 2010 – The journal Contraception publishes a study concluding that “Side effects from the copper IUD can be troubling for both user and clinician. Some problems improve over time while others do not.”

August 2014 – Users of hormonal and non-hormonal contraceptive methods, including copper IUDs, gained a significant amount of weight over a treatment period of up to ten years in a study published in The European Journal of Contraception & Reproductive Health Care.

October 2015 – A review published in the Open Journal of Clinical & Medical Case Reports indicates that while “the safe and effective use of IUD contraception has been demonstrated in the United States, the possibility of its breakage should be recognized by clinicians.”

March 2017 – The American Journal of Obstetrics & Gynecology publishes a study comparing the Paragard IUD and Mirena IUD, an intrauterine device containing the hormone levonorgestrel. According to the study findings, 10.2% of women using Paragard experienced expulsion (migration of the IUD to another part of the body or total expulsion from the body), compared to 4.9% of Mirena users. The researchers also note that during the first year of use, 1.6% of Paragard users became pregnant, compared to 0.1% of Mirena users.

June 2017 – In a randomized study comparing the Paragard IUD to VeraCept, a new copper IUD currently being studied in the U.S., researchers found that VeraCept provided a similar level of contraceptive efficacy compared to Paragard but with less pain at insertion, fewer IUD expulsions and increased total continuation.

October 2020 – Research published in the Journal of Health Sciences and Medicine suggests that women using a copper IUD like Paragard may face an increased risk of pelvic inflammatory disease.

Why We Think Teva and Cooper Should be Held Liable for Paragard IUD Complications

More than 200 million women worldwide use the Paragard copper IUD. Unfortunately, the increase in the number of women choosing IUDs over other methods of birth control has resulted in a surge of reports of unexpected complications and side effects associated with the IUD devices. When choosing the method of birth control that works best for them, women rely on drug and device manufacturers to provide safe and effective products and to be forthright about the potential risks of their products. However, thousands of patients and medical professionals nationwide have reported severe side effects allegedly caused by Paragard IUD, including at least 15 deaths. Paragard IUD lawsuits against Teva and Cooper allege the following:

  • The Paragard IUD was defectively designed and manufactured.
  • The manufacturers misrepresented the Paragard IUD as a safe and effective form of birth control.
  • Consumer complaints and trials conducted by Teva clearly demonstrated the potential safety risks of the Paragard IUD.
  • The manufacturers failed to warn patients or healthcare providers that the Paragard IUD could cause serious complications or that the arms of the birth control device could break during removal and remain in the body.
  • The manufacturers overstated the benefits of Paragard while downplaying the risks of the birth control device.

What should you do? If you believe you have been harmed by side effects allegedly caused by a Paragard IUD, you should contact a lawyer as soon as possible to discuss filing a lawsuit against the medical device manufacturing company.

For more than 30 years, Paragard IUD has been used by women across the country who have been made to believe that the device is safer and more effective than other IUDs and hormonal birth control methods. Unfortunately, many women implanted with the Paragard IUD are unaware of the potential side effects of the birth control device, which have not been properly disclosed to the public or the medical community. If you or a member of your family experienced complications allegedly caused by the defective design or manufacturing of the Paragard IUD, you may have grounds to file a product liability lawsuit against Teva and Cooper Companies, seeking financial compensation for chronic pain, medical bills, lost wages, emotional trauma, loss of reproductive health, loss of enjoyment of life and other damages. Our consumer advocates at the Consumer Justice Foundation are committed to protecting the rights of consumers harmed by defective medical products and we can help put you in touch with an experienced Paragard IUD injury attorney who can review your case and determine whether you may be eligible for compensation.

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