Why is ParaGard IUD Bad? Find Out The Truth

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Fact-Checked by: Lorelei Tucker, Ph.D.

Introduction

Since antiquity, women have sought ways to control their reproductive health to differing levels of success. A plethora of effective birth control methods has been developed in modern times, offering users options to match their specific needs and lifestyles. ParaGard, a copper-based intra-uterine device, is a highly effective modern form of birth control. While it can be appropriate for some users, there are important considerations to be made before choosing any contraceptive. Unfortunately, Teva Pharmaceuticals, the manufacturers of ParaGard have not made the risks of their device fully clear to consumers. This article will examine these risks to provide prospective users with the knowledge they need to make an informed choice.

IntraUterine Devices

IUDs are small metal or plastic devices made that are designed to be inserted into the uterus as a form of birth control. IUDs are popular because they only require a single outpatient procedure and provide effective protection for years [1]. There are many kinds of IUDs, but they largely fall into one of two categories, hormonal and copper. Hormonal IUDs are made of plastic and slowly release progestin into your body, a hormone that helps prevent pregnancy. These have the added benefit of reducing period symptoms for some users. Hormonal IUDs have overlapping side effects to oral contraceptives and last for approximately 3-5 years [1].

ParaGard Copper IUD

Copper IUDs like ParaGard prevent pregnancy by releasing copper ions into the uterus. This effectively paralyzes the sperm, preventing them from meeting with the egg and fertilizing it [2]. Copper IUDs are unique in that they also can be used as a highly effective form of emergency contraception. If inserted within 120 hours of unprotected sex, copper IUDs can prevent an unwanted pregnancy with extreme efficacy [3]. They also last up to 12 years without replacement, a considerable amount of time.

In general, copper IUDs are a safe birth control method. Still, the ParaGard IUD carries risks that aren’t effectively communicated to patients or care providers by the manufacturer.

Benefits

While this article will highlight the negative side-effects and complications associated with ParaGard, it is important to point out its merits. The longevity of its effects and its relative affordability make it an essential tool for birth control in rural and remote areas where maintaining a steady supply of other forms of birth control is not feasible [4].

Furthermore, it is a safe form of postpartum birth control because it does not contain hormones that could be passed to a nursing infant through breastfeeding. Postpartum insertion of IUDs, however, does increase the rate of expulsion or uterine perforation, meaning it is not a silver bullet for postpartum birth control [5]. Finally, it must be noted that the more severe complications of ParaGard are rare, occurring in one in one thousand insertions [6].

Side-Effects of Paragard

Hormonal IUDs are often recommended because they can reduce the severity of menstrual flow, but copper IUDs like ParaGard do the opposite. This leads to more extended and more severe periods [7]. Other commonly reported side effects include expulsion of the device as well as pain [8]. Expulsion is more likely in IUDs inserted shortly after delivery [9].

Complications

One rare complication with ParaGard is that the copper ions released into the uterus can exacerbate symptoms of Wilson’s Disease, a disorder of copper sensitivity [10]. Ectopic pregnancy, where the embryo implants somewhere other than the main body of the uterus, is a risk if pregnancy does occur [1]. The most notable, if rare, complication involving ParaGard and other copper IUDs is IUD uterine perforation [11].

IUD Uterine Perforation

Paragard uterine perforation falls into two classes: complete and partial. In complete uterine perforation, an IUD fragment pierces through the uterine wall and into the body cavity. Partial uterine perforation occurs when the IUD gets embedded in the wall of the uterus. This form of perforation is less common [11].

Uterine perforation is rare, occurring in 1/1000 insertions, and often is asymptomatic  [6]. This means it can go unnoticed for some time [12]. Regardless, it can be dangerous and can damage other organs, most commonly the bowels and urinary tract [13, 14].

Uterine perforation usually requires surgery to remove, especially if the user is planning a future pregnancy [11]. However, since the condition is relatively rare, many ParaGard users miss the telltale symptoms of IUD uterine perforation. This can delay treatment and worsen outcomes.

Legal Troubles

In recent years, many users have filed lawsuits against Teva Pharmaceuticals after experiencing breakage upon removal that led to IUD uterine perforation. Plaintiffs claim that Teva did not fully inform patients or providers of ParaGard breakage or perforation risks [15]. In a recent case study, one patient required a hysterectomy after uterine perforation [16].

If you or a loved one suffered such an injury from the use of ParaGard, you might be entitled to compensation. Please contact us today to schedule a consultation.

Frequently Asked Questions

What are the most common side effects of ParaGard?

Side effects usually include intensified menstrual flow and pain, occurring most commonly in the first 6 months of use [7].

What is the most serious complication of ParaGard?

Uterine Perforation is the most significant complication of ParaGard, and occurs in 1 out of every 1,000 insertions [6].

What kind of damage can ParaGard uterine perforation cause?

ParaGard uterine perforation is often asymptomatic, but it can lead to damage to the bowels and urinary tracts [13, 14]. In very rare cases, removal may require a hysterectomy [16].

  1.       Lanzola, E.L. and K. Ketvertis, Intrauterine Device, in StatPearls. 2021: Treasure Island (FL).
  2.       Roblero, L., et al., Effect of copper ion on the motility, viability, acrosome reaction and fertilizing capacity of human spermatozoa in vitro. Reprod Fertil Dev, 1996. 8(5): p. 871-4.
  3.       Kaislasuo, J., et al., Uterine perforation caused by intrauterine devices: clinical course and treatment. Hum Reprod, 2013. 28(6): p. 1546-51.
  4.       Lilja, K., et al., Clinical availability of the copper IUD in rural versus urban settings: A simulated patient study. Contracept X, 2021. 3: p. 100059.
  5.       Kennedy, K.I., Post-partum contraception. Baillieres Clin Obstet Gynaecol, 1996. 10(1): p. 25-41.
  6.       Heinemann, K., et al., Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception, 2015. 91(4): p. 280-3.
  7.       Kaneshiro, B. and T. Aeby, Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device. Int J Womens Health, 2010. 2: p. 211-20.
  8.       Akintomide, H., et al., Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 – a secondary analysis of the EURAS-IUD study. Eur J Contracept Reprod Health Care, 2021: p. 1-9.
  9.       Goldthwaite, L.M., et al., Postpartum intrauterine devices: clinical and programmatic review. Am J Obstet Gynecol, 2018. 219(3): p. 235-241.
  10.     Horvath, S., C.A. Schreiber, and S. Sonalkar, Contraception, in Endotext, K.R. Feingold, et al., Editors. 2000: South Dartmouth (MA).
  11.     Rowlands, S., E. Oloto, and D.H. Horwell, Intrauterine devices and risk of uterine perforation: current perspectives. Open Access J Contracept, 2016. 7: p. 19-32.
  12.     Harrison-Woolrych, M., J. Ashton, and D. Coulter, Uterine perforation on intrauterine device insertion: is the incidence higher than previously reported? Contraception, 2003. 67(1): p. 53-6.
  13.     Tabatabaei, F. and M. Masoumzadeh, Dislocated intrauterine devices: clinical presentations, diagnosis and management. Eur J Contracept Reprod Health Care, 2021. 26(2): p. 160-166.
  14.     Sepulveda, W.H., et al., Sonographic diagnosis of bladder perforation by an intrauterine device. A case report. J Reprod Med, 1993. 38(11): p. 911-3.
  15.     UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION IN RE: PARAGARD IUD PRODUCTS. 2020.
  16.     Sarver, J., M. Cregan, and D. Cain, Fractured copper intrauterine device (IUD) retained in the uterine wall leading to hysterectomy: A case report. Case Rep Womens Health, 2021. 29: p. e00287.

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