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Migration Season for Mirena IUD Perceptions?

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Elizabethtown, KYMirena birth control side effects have become an even greater concern since IUD contraceptive products like Mirena are now covered for women under improvements to the US Health Act, and thus available to even more women than before.

However, in contrast to Mirena side effects that include the possibility of IUD migration and other complications, is a recent survey of 1,600 US women between the ages of 18 and 50 that reveals various “perceptions and misconceptions” related to a somewhat controversial method of birth control.

The survey, conducted by US researchers and featured in a Reuters Health article published by the San Jose Mercury News (2/22/13), found that women may have inaccurate perceptions about the safety and effectiveness of IUDs for pregnancy prevention.

The tone of the survey was decidedly favorable to the intrauterine device, or IUD. As an example, according to the report, many of the study participants didn’t know that IUDs such as Mirena are more effective contraceptives than oral birth control, and do not increase the risk of acquiring a sexually transmitted disease.

However, in quantifying the efficacy and effectiveness, the survey noted that IUDs are more than 99 percent effective at preventing pregnancy, as compared with oral contraceptives that were found, in real-world practice, to be about 95 percent effective.

That’s only about a four percent difference. And in bullishly supporting the safety and effectiveness of the IUD as compared with oral birth control, there was no mention of incidents of painful and dangerous uterine perforations and vaginal hemorrhaging, device dislocation or migration, or intrauterine pregnancy.

“It’s not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,” said Dr. Lisa Callegari, the study’s lead author and a clinical assistant professor at the University of Washington.

The article did not include the question or questions directed to survey respondents that served to generate the responses.

Was the survey weighted in such a way as to generate a positive response?

And was there any reference to a 2009 warning to Mirena manufacturer Bayer by the US Food and Drug Administration (FDA) for overstating the effectiveness of Mirena while minimizing the risks? According to the FDA warning, busy moms were targeted with claims of ease of use and an increase in libido, when in practice, five percent of Mirena participants in clinical trials reported decreased libido.

If there is a pessimistic disconnect amongst women with regard to IUD, could it be because they were paying attention when the FDA issued its Bayer Mirena warnings?

In an unrelated incident, a doctor hailing from Elizabethtown is facing a 13-count federal grand jury indictment for allegedly purchasing foreign versions of Mirena and inserting them into his patients.

The Courier-Journal (3/22/13) reports Dr. Canh Jeff Vo, who owned and served as the supervising physician of Bluegrass Women’s Healthcare in Elizabethtown between March 2008 and September 2009, is alleged to have purchased versions of Mirena IUDs from Canada and other countries that did not carry FDA approval. According to the investigation, which lasted three years, the devices carried labels that were not in English and did not include adequate directions. As such, they were misbranded.

Vo caught the wrath of the US Attorney for the Western District of Kentucky David J. Hale, Attorney General Jack Conway, and the FDA - all of whom participated in the investigation. Vo is accused of billing the state Medicaid program in Kentucky for FDA-approved Mirena IUDs, when in reality (it is alleged), he used the off-market devices. Of his 13-count charge, Vo is facing 10 counts of mail fraud for using the US mail to receive payment from Medicaid and private insurance companies.

While Bayer cannot be held accountable for the actions of an allegedly disreputable doctor, the manufacturer has been previously called to the carpet by the FDA for overstating the safety and effectiveness of its Mirena product while minimizing the risks of Mirena birth control side effects.

Those Mirena side effects include the potential for Mirena uterine perforation and migration.

Perhaps, if various survey respondents harbor a pessimistic view of Mirena, there is a foundation for that pessimism beyond expert claims to the contrary…


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