NuvaRing Evaluation Criteria

Introduction:

NuvaRing is a contraceptive birth control ring that was originally manufactured by Organon and is now being distributed and sold by Merck. Since the FDA first approved NuvaRing in 2001, millions of women have used the ring for contraception instead of using oral contraceptive. It is a flexible ring about 2 inches in diameter that a woman inserts into the vagina once a month to prevent pregnancy.

The combination of hormones released by NuvaRing prevents ovulation, changes cervical mucus (making it difficult for sperm to enter), and reduces the likelihood of implantation. NuvaRing does not prevent menstrual cycles or protect against sexually transmitted diseases. If the ring comes out, which is rare, it can be rinsed and reinserted within three hours. It is not known to disrupt sexual intercourse. To prevent pregnancy, the NuvaRing delivers smaller amounts of hormones. Unlike birth control pills that must be taken each day, the NuvaRing only has to be replaced every three weeks.

It releases a continuous daily dose of 0.120 mg of etonogestrel (progestin) and 0.015 mg of ethinyl estradiol (estrogen) and is 99 percent effective at preventing pregnancy.

Over the past few years, there have been many reports that NuvaRing causes many different life-threatening health problems. According to various studies to determine how safe NuvaRing is to use, women who use the NuvaRing are at an increased of having a stroke, developing blood clots and deep vein thrombosis also known as DVT To date, over 1,000 complaints have been filed with the FDA by women and their families. Thousands of women have sustained serious personal injuries and many have died after using the NuvaRing.

Case Review Focus Areas:

1.       Was the IUD placed?
2.       Did the patient have any preexisting conditions, allergies or contraindications for the device
3.       Past medical history – Any prior IUD placement, OBGYN medical issues from history?

E.g.: Past Medical History: Conditions affecting genito-urinary tract.

4.       Need for IUD placement?
5.       Was she a right candidate for IUD placement?
6.       Did the patient develop Complications after IUD placement?
7.       Treatment/management – Operative procedure, indications, complications, pathology and findings of side effects
8.       Follow-up visits for side effects or complications
9.       Outcome/prognosis
10.   Has IUD been advised to be removed?  If so, for what reason?
11.   Any medical/surgical history, social history (smoking) that could have had an effect on the injury

Insertion:  NuvaRing is a small, comfortable vaginal ring that’s easy to insert and remove by the patient. The exact position of NuvaRing is not important for it to be effective. Once inserted, NuvaRing should stay in place. NuvaRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement.

Potentially fatal side effects of NuvaRing birth control include:

  • Deep vein thrombosis – a blood clot in the deep vein, normally on the leg or pelvic area
  • Pulmonary embolism – a blood clot that is lodged into your lungs
  • Stroke – a blood clot that is lodged into the brain

Other Side Effects of NuvaRing

  • Vaginal infection and irritation
  • Headache
  • Weight gain
  • Vaginal secretion and nausea.
  • Combination hormonal contraceptives, including NuvaRing, can worsen conditions like high blood pressure, diabetes, and problems with cholesterol and triglycerides.

Additional side effects

In addition to the risks and side effects listed above, users of combination hormonal birth control methods have also reported the following side effects:

  • Vomiting
  • Change in appetite
  • Abdominal cramps and bloating
  • Breast tenderness or enlargement
  • Irregular vaginal bleeding or spotting
  • Changes in menstrual cycle
  • Temporary infertility after treatment
  • Fluid retention (edema)
  • Spotty darkening of the skin, particularly on the face
  • Rash
  • Weight changes
  • Depression
  • Intolerance to contact lenses
  • Nervousness
  • Dizziness
  • Loss of scalp hair

Diagnosis and management of the complication:

  • Whether the above mentioned symptoms were identified as a complication of IUD placement?
  • Was it managed medically
  • Medical status of the patient?
  • Progress of the patient after removal

Contraindications: (Do not use NuvaRing if you have any of the following conditions)

  • NuvaRing is not for women with certain cancers or those who may be pregnant.
  • Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women, who use combination hormonal contraceptives, including NuvaRing, are strongly advised not to smoke.
  • A history of heart attack or stroke
  • A history of blood clots in your legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • Chest pain (angina pectoris)
  • Severe high blood pressure
  • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
  • Headaches with neurological symptoms
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina (now or in the past)
  • Unexplained vaginal bleeding (until a diagnosis is reached by your health care professional)
  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal birth control of any kind (the Pill, patch, vaginal ring, injection, or implant)
  • Liver tumor (benign or cancerous)
  • Heart valve or heart rhythm disorders that may be associated with formation of blood clots
  • Need for a long period of bed rest following major surgery
  • Known or suspected pregnancy
  • Active liver disease with abnormal liver function tests
  • An allergy or hypersensitivity to any of the components of NuvaRing 

Missing records notification to Client

Important records related to

  • Product use
  • Injury details
  • Missing records have to be identified and confirmed with MD Specialist and should be communicated to the client

Final Review by MD Specialist

  • Chronology is reviewed by the MD Specialist before delivery. OBGYN Specialist opinion considered if there is a need.

Other information about the product:

Risk Of Blood Clots And Heart Problems With Nuvaring

The most serious side effects associated with NuvaRing are the increased risk of blood clots, heart attack and stroke. NuvaRing may increase the risk of these conditions because it contains etonogestrel, an active metabolite of desogestrel in the progestin hormone family. This hormone is also used in birth control pills. Desogestrel is considered a third-generation progestin, while some birth control pills use fourth-generation progestins.

Third- and fourth-generation progestins have been linked to increased risk of deep vein thrombosis (DVT) (blood clots) and pulmonary embolism (PE) (blood clots in the lungs). In addition, the risk of heart attack and stroke is also increased. These complications can lead to death.

NuvaRing’s labeling information includes warnings of risks of venous, arterial and pulmonary embolisms. Arterial embolisms form in the arteries and can lead to myocardial infarction (heart attack). Venous thromboembolisms (VTEs) are blood clots that form in the veins and may start in the legs, arms or groin, then break loose and travel to the lungs. When the clot is in the lungs, it is called a pulmonary embolism, and can block the airways and become fatal. NuvaRing releases low daily doses of hormones, but unlike the oral third-generation contraceptives, the hormones from NuvaRing are directly absorbed by the body. About half of the hormones released by oral contraceptives disappear in the digestive tract. There has not yet been a definitive study to show how much more harmful NuvaRing’s level of absorption may be. However, the mounting reports of adverse events suggest that NuvaRing may pose a greater threat than other combined hormone contraceptives.

Warning Signs of a Possible Blood Clot.

Symptoms of a blood clot include:

  • Swelling of arm or leg
  • A warm spot on the leg
  • Skin redness
  • Soreness or pain in the arm or leg

Signs that the clot may have moved to the lungs include:

  • Chest pain
  • Difficulty breathing
  • Fast heartbeat
  • Fainting spells
  • Cough, with or without blood
  • Mild fever