ParaGard IUD

  • Paragard-Medical-Record-Review-Outsourcing Services

ParaGard, a small IUD (intrauterine device) that is used to prevent pregnancy works differently using one simple active ingredient, copper, instead of hormones, unlike its other counterparts. It is a T shaped device and can help avoid pregnancy for upto 10 years.

The copper present in the device is continuously released into the uterine cavity, which interferes with the sperm transport or fertilization, and prevention of implantation.

The use of IUD results in less than 1 pregnancy per 100 women each year as per the pregnancy rate in clinical studies. The FDA approved five IUD brands for sale in the U.S.: Mirena, Kyleena, Liletta, Skyla and ParaGuard.

IUD manufactured by Finishing Enterprises Inc. was FDA-approved on 11/15/1984. The device was approved for use of only 4 years, but the use was extended to 10 years in 1994.

Common Side Effects:

  • Anemia
  • Backache
  • Dysmenorrhea
  • Dyspareunia
  • Expulsion, complete or partial
  • Leukorrhea
  • Menstrual flow, prolonged
  • Menstrual spotting
  • Pain and cramping
  • Urticarial allergic skin reaction
  • Vaginitis

Serious Alleged Injuries may include:

  • IUD “stuck” in the uterus
  • Perforation of the uterus
  • Migration of the device
  • Device breakage leading to surgery
  • Copper wire left behind in the body, potentially causing inflammation and injury
  • Infections
  • Scarring
  • Organ damage
  • Ectopic pregnancy

FDA Safety Warnings:

April 2014: A batch of ParaGard T 380A Intrauterine Copper Contraceptive devices were recalled due to a lack of assurance of sterility by the FDA.

The FDA has given the following Warnings & Instruction over the use of ParaGard:

Ectopic Pregnancy: Promptly evaluate women who become pregnant for ectopic pregnancy while using ParaGard.

Risks with Intrauterine Pregnancy: Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove ParaGard if pregnancy occurs with the device in place.

Sepsis: Group A streptococcal infection has been reported; the strict aseptic technique is essential during insertion.

Pelvic Inflammatory Disease (PID) and Endometritis: Before using ParaGard, consider the risks of PID and endometritis. Promptly assess and treat patients with signs and symptoms of PID.

Embedment: Surgical removal may be necessary.

Perforation: May reduce contraceptive effectiveness and require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed, retroverted uteri or convoluted uteri.

Expulsion: Partial or complete expulsion may occur. Remove a partially expelled ParaGard.

Bleeding patterns: Maybe altered and result in heavier and longer bleeding with spotting.

MRI Safety Information: Patients using ParaGard can be safely scanned with MRI only under certain conditions.

Legal Updates:

Defendants:

Teva Pharmaceuticals         

Defendant Law Firm:

Teva is represented by Ulmer & Berne LLP.

Allegations: Lawsuits allege that the manufacturer failed to provide adequate warning about the risks of the ParaGard breaking and potentially perforating the uterus.

Lawsuit Status: Several lawsuits have been filed against Teva charging with failure to warn, negligence, breach of warranty, misrepresentation, and designing a defective product. The lawsuits are pending in their individual courts, and an MDL is yet to be formed.

MDL Status: Not yet formed.

Important Verdicts & Settlements: Currently there are no settlements made.

Evidence:

  • Duration of Usage
  • Indication of usage in Medical Records
  • Evidence of injury in follow up medical records

Medical Record Review and claim validation of ParaGard IUD case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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