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CONTRAINDICATIONS

MIRENA insertion is contraindicated when one or more of the following conditions exist:

1. Pregnancy or suspicion of pregnancy.

2. Congenital or acquired uterine anomaly including fibroids if they

distort the uterine cavity.

3. Acute pelvic inflammatory disease or a history of pelvic

inflammatory disease unless there has been a subsequent

intrauterine pregnancy.

4. Postpartum endometritis or infected abortion in the past

3 months.

5. Known or suspected uterine or cervical neoplasia or unresolved,

abnormal Pap smear.

6. Genital bleeding of unknown etiology.

7. Untreated acute cervicitis or vaginitis, including bacterial

vaginosis or other lower genital tract infections until infection

is controlled.

8. Acute liver disease or liver tumor (benign or malignant).

9. Woman or her partner has multiple sexual partners.

10. Conditions associated with increased susceptibility to infections

with micro-organisms. Such conditions include, but are not

limited to, leukemia, acquired immune deficiency syndrome

(AIDS), and I.V. drug abuse.

11. Genital actinomycosis

12. A previously inserted IUD that has not been removed.

13. Hypersensitivity to any component of this product.

14. Known or suspected carcinoma of the breast.

15. History of ectopic pregnancy or condition that would predis-

pose to ectopic pregnancy.

WARNINGS

1. Ectopic Pregnancy

In large clinical trials of MIRENA, half of all pregnancies detected

during the studies were ectopic. The per-year incidence of ectopic

pregnancy in the clinical trials was approximately 1 ectopic

pregnancy per 1000 users per year. The rate of ectopic pregnan-

cies associated with MIRENA use is not significantly different than

the rate for sexually active women not using any contraception.

Clinical trials of MIRENA excluded women with a history of

ectopic pregnancy. MIRENA is not recommended for use in

women with a history of ectopic pregnancy or conditions that

increase the risk of ectopic pregnancy. Women who choose

MIRENA must be warned about the risks of ectopic pregnancy.

They should be taught to recognize and report to their physician

promptly any symptoms of ectopic pregnancy. Women should

also be informed that ectopic pregnancy has been associated with

complications leading to loss of fertility.

She should be followed closely and advised to report immediately

any flu-like symptoms, fever, chills, cramping, pain, bleeding,

vaginal discharge or leakage of fluid.

c. Long-term effects and congenital anomalies

When pregnancy continues with MIRENA in place, long-term

effects on the offspring are unknown. Because of the intrauterine

administration of levonorgestrel and local exposure to the

hormone, the possibility of teratogenicity following exposure to

MIRENA, especially virilization, cannot be completely excluded.

Clinical experience with the outcomes of pregnancies is limited

due to the small number of reported pregnancies following

exposure to MIRENA.

Congenital anomalies have occurred infrequently when MIRENA

has been in place during pregnancy. In these cases the role of

MIRENA in the development of the congenital anomalies is

unknown. As of September 1999, 32 live births following exposure

to MIRENA were reported retrospectively. All but 2 of the infants

were healthy at birth. One infant had pulmonary artery hypoplasia

and another infant had cystic hypoplastic kidneys. (A sibling of this

infant had renal agenesis with no MIRENA exposure.)

3. Sepsis

As of 1999, four cases of Group A streptococcal sepsis (GAS) out

of an estimated 1.3 million MIRENA users were reported. All four

women experienced the symptom of severe pain within hours of

insertion, and this was followed by sepsis within a few days (of

insertion). All recovered with treatment. Since death from GAS is

more likely if treatment is delayed, it is important to be aware of these

rare but serious infections. Aseptic technique during MIRENA

insertion is essential. (GAS sepsis can also occur postpartum, after

minor surgery, in wounds and in association with other IUDs.)

4. Pelvic Inflammatory Disease (PID)

MIRENA is contraindicated in the presence of known or suspected

PID or in women with a history of PID unless there has been a

subsequent intrauterine pregnancy. Use of IUDs has been associ-

ated with an increased risk of PID. The highest risk of PID occurs

shortly after insertion (usually within the first 20 days thereafter)
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