Paragard

Manufacturer 

 

Teva Pharmaceuticals                                        $12.92 Billion
Paragard T380A
CooperSurgical, Inc.                                           $16.08 Billion
(The Cooper Companies, Inc.)

 

FDA Approval 

 

Paragard T380A                                          NDA 18-680                           November 15, 1984
 
                                                                       505 (b)                   

Theories

Strict Liability – Failure to Warn, Design Defect, Manufacturing Defect
General Negligence – Accepted across the board from all states

 

MDL Information 

 

Seeking Mass Tort in Philadelphia Court of Common Pleas (PCCP)
1 case currently pending remains in Eastern District of Pennsylvania

Background

According to Paragard.com, Paragard is a small, hormone-free IUD made of soft, flexible plastic wrapped with a thin layer of copper. It’s placed in your uterus by a healthcare provider during an office visit in just a few minutes.
 
 
Paragard is a different kind of birth control that works to prevent pregnancy without any hormones at all. It’s the only birth control that works as well as hormonal birth control but is 100% hormone-free—meaning you get the pregnancy prevention you need, without the added hormones that you don’t.
 
 
Paragard is the longest lasting prescription birth control method available—providing continuous pregnancy prevention for up to 10 years—2x longer than the longest lasting hormonal IUD. Paragard lasts up to 10 years, but can be removed at any time sooner. If you decide you want to get pregnant or stop using it, your healthcare provider can remove it. And because Paragard is hormone-free, it doesn’t stop you from ovulating each month, so when it’s removed your ability to get pregnant will return immediately.
 
 
On November 1, 2017, The Cooper Companies, Inc. announced it completed its previously announced purchase of the assets and global rights and business of the PARAGARD® Intrauterine Device (IUD) from Teva Pharmaceutical Industries Ltd., for a purchase price of approximately $1.1 billion.  Paragard is made in the USA.

Paragard was approved through an NDA for 4 year use in 1984.  In 1989, Paragard was extended to 6 years of use, and in 1991, it was approved for 8 years of use.  Finally, in 1994, it was extended to 10 years of use.  Interestingly, the owner touted 12 years of use in a pamphlet, but it was done so without FDA approval.
 
 
Sales figures for Paragard are difficult to obtain.  Based upon reports, when The Cooper Companies announced the acquisition of Paragard from Teva, Paragard had sales of only $168 million from July 2016 through June 2017, which would equate to approximately 336,000 implants at $500 each.
 
 
According to a published 2018 report, researchers reported that a record 4.4 million, or 7.8% of all U.S. women, now use IUDs, compared to only 1.5% of women in 2002.

 

Treatment / Use

 
According to Paragard.com, Paragard is over 99% effective at preventing pregnancy and one of the most effective methods of birth control available. It’s more effective than any other hormone-free birth control method*—and most hormonal methods. In fact, the
 
American College of Obstetricians and Gynecologists (ACOG) recommends Paragard as one of the most reliable ways of preventing pregnancy.
 
 
Paragard works using just 1 simple active ingredient—copper—instead of artificial hormones. The copper in Paragard is clinically proven safe and effective for pregnancy prevention and has been FDA-approved for over 30 years.
 
 
Paragard is a no-hassle, low maintenance birth control. Once in place, Paragard provides continuous pregnancy prevention without the need for a daily birth control routine.
 
 
Because Paragard is hormone-free, there’s no hormones, no hassles, no hormone related side effects.

Injuries / Complications / Concerns

 
A Nebraska woman, Stephanie Ideus was one of the people who filed a suit against Teva Pharmaceuticals, one of the manufacturers of the device, in 2016. During her Paragard IUD removal, the device broke and imbedded in her uterus, and she required surgery to have it removed, according to her complaint.
 
Ideus and other women who filed lawsuits against Teva claimed the side effect they weren’t properly warned about was device breakage. They also say the company misrepresented the device as safe and effective even if the device was actually defective.
 
There have been additional concerns about the product, but the warnings for Paragard, INCLUDE:  Ectopic Pregnancy, Risks with Intrauterine Pregnancy, Sepsis, Pelvic Inflammatory Disease (PID), Embedment, Perforation, Expulsion, Bleeding Patterns, and MRI Safety Information.
 
Injuries associated with Paragard fracture/breakage include: perforation of the uterus, migration, copper wire left in the body, infections, scarring, organ damage, severe pain associated with the broken device, PTC, removal surgery and hysterectomy.  It has been reported that since 2010, the FDA has received more than 2,800 reports of unexpected Paragard breakage.
Fracturing or breakage of the device is the problem with the device.  The plastic will deionize over time, which leads to breaking.  The arm will break on its own, or during the removal process, at the shoulder region of the device.  The broken arm is sharp.  During removal, the uterus wall contracts, which causes the broken arm piece to puncture the uterine cavity, and migrates.
 
When breakage occurs, laparoscopy is performed to find the broken arm.  Concerns are that if a woman wants to become pregnant, you can’t puncture the abdominal wall too many times.  It’s likely that a woman must wait 1-2 years before she can become pregnant again.  It’s also likely that multiple ultrasounds will need to be performed to find the broken arm, and many women still have the arm within them, since it is nearly impossible to remove.
 
There are surgical options to remove the arm, including C-Section, Hysterectomy (removal of uterus, which eliminates the ability to become pregnant), and Hysteroscopy.

Information on the Topic of Paragard

 

Lawsuits by Missouri Women Claim IUD Broke During Removal (9-23-2020)

https://www.kcur.org/health/2020-09-23/lawsuits-by-missouri-women-claim-iud-broke-during-removal

 

FDA Approved Drugs – NDA 018680 (6-2020)

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018680

 

Barcelo v Teva Pharmaceuticals; The Cooper Companies and CooperSurgical – Memorandum and Opinion (4-2-2020)

https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_20-cv-00017/pdf/USCOURTS-txsd-4_20-cv-00017-2.pdf

 

Paragard Prescribing Information (2-2020)

https://14wub23xi2gmhufxjmvfmt1d-wpengine.netdna-ssl.com/wp-content/uploads/2018/10/PARAGARD-PI.pdf

 

Intrauterine Contraception: Management of Side Effects and Complications

(2-19-2019)

https://www.uptodate.com/contents/intrauterine-contraception-management-of-side-effects-and-complications

 

Historical Record-Setting Trends in IUD Use in the United States (12-1-2018)

https://www.contraceptionjournal.org/article/S0010-7824(18)30192-6/pdf

Expulsion of a Spontaneously Broken Arm of a T-Shaped IUD: A Case Report (2018)

https://www.arcjournals.org/ajphcm/volume-3-issue-2/5

 

The Cooper Companies Completes Acquisition of PARAGARD® IUD From Teva

(11-1-2017)

http://investor.coopercos.com/news-releases/news-release-details/cooper-companies-completes-acquisition-paragardr-iud-teva

 

The Cooper Companies Announces Definitive Agreement to Acquire Paragard IUD from Teva (9-11-2017)

https://www.globenewswire.com/news-release/2017/09/11/1117681/0/en/The-Cooper-Companies-Announces-Definitive-Agreement-to-Acquire-PARAGARD-IUD-From-Teva.html

 

Paragard IUD Broke, Causing Harm, Suit Against Teva Says (6-15-2016)

https://news.bloomberglaw.com/pharma-and-life-sciences/paragard-iud-broke-causing-harm-suit-against-teva-says

Spontaneous Fracture and Vaginal Expulsion of the Arm of Intra-Uterine Device: Case Report (4-2016)

https://www.researchgate.net/publication/307721296_Spontaneous_Fracture_and_Vaginal_Expulsion_of_the_Arm_of_Intra-Uterine_Device_Case_Report

 

The “Broken” IUD: Its Detection and Clinical Management (2015)

http://jclinmedcasereports.com/articles/OJCMCR-1049.pdf

 

Role of Uterine Forces in Intrauterine Device Embedment, Perforation, and Expulsion (8-7-2014)

https://www.dovepress.com/role-of-uterine-forces-in-intrauterine-device-embedment-perforation-an-peer-reviewed-fulltext-article-IJWH

 

Fractured Intrauterine Device Copper Sheath with an Intact Polyethylene Core (2013)

https://onlinelibrary.wiley.com/doi/pdf/10.7863/ultra.32.10.1877

 

Paragard Prescribing Information (6-2013)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf

Migration of Intrauterine Devices: Radiologic Findings and Implications for Patient Care (3-5-2012)

https://pubs.rsna.org/doi/10.1148/rg.322115068

 

Contraceptive Comeback: The Maligned IUD Gets a Second Chance (7-5-2011)

https://www.wired.com/2011/07/ff_iud/

 

FDA Approval Package for NDA 18-680 (11-15-1984)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018680_original_approval.pdf