From: bron@iastate.edu (bronwyn)
Subject: Re: Norplant side effects
Originator: bron@tbird.cc.iastate.edu
Organization: Iowa State University, Ames, IA
Date: Wed, 30 Dec 1992 11:03:13 GMT

In article <1992Dec29.100313.1@sscvx1.ssc.gov> abraham@sscvx1.ssc.gov writes:
>What are the side effects of using 'Norplant' for birth control ?

Personally, I've experienced few.  The most obvious one I've experienced is
a reduction in the frequency of my period.  Oh, how 'orrible ;) ;) ;)
I have full patient labeling for interested parties.  

Information below is reproduced without permission from Wyeth-Ayerst 
Laboratories patient labeling for the Norplant System (r):  

Risks of Using the Norplant System
----------------------------------

1. Irregular Menstrual Bleeding
 Most women experience some change in their usual monthly pattern.
 These menstrual irregularities vary from woman to woman and
 include:
  * Prolonged bleeding (more days than you usually experience),
    commonly during the first months of use;
  * Untimely bleeding or spotting between periods;
  * No bleeding at all for several months; or
  * A combination of these patterns.
 It cannot be predicted what kind of change you may experience. If
 increased frequency of bleeding occurs, the quantity of blood lost
 is rarely enough to cause anemia, but there have been a few cases
 that required treatment. The irregularities frequently diminish
 gradually with continued use.

2. Delayed Disintegration or Disappearance of Follicles
 If follicles (eggs and their surrounding cells) in the ovary
 develop while using the Norplant System, disintegration or
 disappearance of the follicles is sometimes delayed, and the
 follicles may continue to grow beyond the size they would normally
 reach. These enlarged follicles may produce discomfort in some
 women, although most users would not be aware of them unless they
 were found incidentally on a physical exam. In the majority of
 women, enlarged follicles will disappear on their own and should
 not require major surgery. Rarely, they may twist or rupture so
 that surgery is required. You should discuss this with your
 health-care provider. 
3. Ectopic Pregnancies
 Ectopic pregnancies (development of the fertilized egg outside the
 uterus) have occurred among Norplant System users, although
 clinical studies have shown no increase in the rate of ectopic
 pregnancies per year among Norplant System users as compared with
 users of no method or of IUDs. Symptoms of an ectopic pregnancy
 include spotting and cramping pain, which usually begin shortly
 after the first missed period. Contact your health-care provider
 should you miss a period or experience abdominal pain. 
4. Risks Based on Experience with Combination Oral Contraceptives
 Combination pills contain a progestin such as levonorgestrel and
 an estrogen, another type of hormone. Some rare but serious side
 effects have been associated with the use of the combination pill.
 It is unknown whether the risks associated with combined
 oral-contraceptive use may also be risks with a progestin-only
 contraceptive like the Norplant System. Since the hormone is
 released at a low rate, the Norplant System is expected to avoid
 some of the side effects of combined oral contraceptives that not
 only have higher progestin doses but also contain estrogen.
  Risks Associated with Combination Oral Contraceptives Include:
   a. Risk of developing blood clots - Blood clots and blockage of
      blood vessels are the most serious side effects of taking the 
      combination pill. In particular, a clot in the veins of the
      legs can cause inflammation and risk of further clots, and a
      clot that travels to the lungs can cause a sudden blocking of
      the vessel carrying blood to the lungs, resulting in
      respiratory collapse and even death. Rarely, clots occur in
      the blood vessels of the eye and may cause double vision,
      impaired vision, or even blindness.  
   b. Risk of heart attacks and strokes - The combination pill may
      increase the tendency to develop strokes (stoppage or rupture
      of blood vessels in the brain), angina pectoris, or heart
      attacks (blockage of blood vessels to the heart). Any of
      these conditions can cause death or serious disability.
      Smoking greatly increases the probability of suffering heart
      attacks and stroke.  
      Use of combination oral contraceptives together with
      cigarette smoking greatly increases the risk of serious
      adverse effects on the heart and blood vessels. 
      This risk increases with age and with heavy smoking (15 or
      more cigarettes per day) and is quite marked in women over 35
      years of age who smoke. It is not known whether a similar
      interaction occurs with the Norplant System. Therefore, women
      who use the Norplant System should not smoke. 
   c. Gallbladder disease - Combined-pill users probably have a
      greater risk than nonusers of gallbladder disease. Since this
      risk may be related to pills containing high doses of
      estrogens, it may not be a concern for Norplant System users. 
   d. Liver tumors - In rare cases, the combination oral
      contraceptive can cause noncancerous but dangerous liver
      tumors. These benign liver tumors can rupture and cause fatal
      internal bleeding. In addition, a possible but not definite
      association has been found with the pill and liver cancers.
      However, liver cancers are very rare.
   e. Cancer of the reproductive organs - There is, at present, no
      confirmed evidence that combination oral contraceptives
      increase the risk of cancer of the reproductive organs in
      human studies. Recent studies have found no increased risk of
      developing breast cancer in the overall population of users.
      However, some of these same recent studies have found that
      certain subgroups of oral-contraceptive users may be at an
      increased risk, although no consistent pattern has been
      identified. Some studies have found an increase in the
      incidence of cancer of the cervix in women who use oral
      contraceptives. However, this finding may be related to
      factors other than the use of oral contraceptives.  


Side Effects of the Norplant System
-----------------------------------

  The most frequently reported side effects are menstrual cycle
irregularities. Such changes vary from woman to woman and may
include: 
  * Prolonged menstrual bleeding (more days than you would usually
    experience), commonly during the first months of use;
  * Untimely bleeding or spotting between periods;
  * No bleeding at all for several months; or
  * A combination of these patterns.

  It cannot be predicted before insertion of the Norplant System
what kind of bleeding pattern you will have. Many women can expect
an altered bleeding pattern to become more regular after 9 to 12
months. Despite the increased frequency of bleeding in some women,
the monthly blood loss is usually less than normal menses. In fact,
in some studies, patient blood counts have improved. 
  Contact your health-care provider if you experience heavy
bleeding. If you have normal cyclic periods and then miss a period,
a pregnancy test should be obtained. 
  In clinical studies, women using the Norplant system have
complained about the following conditions, which are possibly
related to the Norplant System:
  * Headache;
  * Nervousness;
  * Nausea;
  * Dizziness;
  * Enlargement of the ovaries and/or fallopian tubes;
  * Dermatitis (inflammation of the skin);
  * Acne;
  * Change of appetite;
  * Weight gain;
  * Mastalgia (breast tenderness);
  * Hirstutism (excessive growth of body or facial hair) or
    alopecia (hair loss);
  * Discoloration of the skin over the site of implantation
    (usually reversible).

  Preexisting conditions of acne or excessive growth of body or
facial hair could also be worsened. Occasionally, an infection may
occur at the implant site, or there may be a brief incidence of
pain or itching. Removals may be more difficult than insertions in
some cases. 
  An enlargement of ovarian follicles, detectable during a physical
examination, sometimes occurs in Norplant system users. The
enlarged follicles usually disappear on their own without surgical
intervention, but in rare instances they may twist or rupture, so
that surgery is required. 
  There are a number of other complaints reported by Norplant
System users or discovered by health-care providers, but an
association with the Norplant System has been neither confirmed nor
refuted:
  * Breast discharge;
  * Cervicitis (inflammation of the cervix, detected by physician);
  * Muscle and skeletal pain;
  * Abdominal discomfort;
  * Leukorrhea (whitish discharge from the vagina and uterine
    cavity); 
  * Vaginitis (inflammation of the vagina).


Side Effects Based on Experience with Combination Oral
Contraceptives
--------------

  As with the risks associated with taking combination oral
contraceptives, it is unknown whether the possible side effects
listed below would also occur with a progestin-only contraceptive
like the Norplant System.
  a. Contact lenses - If you wear contact lenses and notice a
     change in vision or an inability to wear your lenses, contact
     your doctor or health-care provider.
  b. Fluid retention - Combination oral contraceptives may cause
     edema (fluid retention) with swelling of the fingers or ankles
     and may raise your blood pressure. If you experience fluid
     retention, contact your doctor or health-care provider. 
  c. Melasma - A spotty darkening of the skin is possible,
     particularly of the face.
  c. Other side effects - Other side effects that have been
     observed with the use of combination oral contraceptives, but
     not necessarily the Norplant System, include depression and
     rash.  


--
Bronwyn J Scrutton                                          bron@iastate.edu
Project Vincent                                               (515) 294-4994
                    If it's not one thing, it's Bronwyn. 
Newsgroups: sci.med