Expert Witness Says there are spikes in NuvaRing’s Hormone Levels

The following Expert Witness Report from Dr. Shelley Tischkau (click here: Tischkau Report to skip to the meat of her analysis, go to page 12) is an analysis of the only study done to measure the levels of estrogen (Ethinylestradiol) and progestin (Etonogestrel).  There was only one study ever done to measure the levels of hormones released when a NuvaRing is inserted.

In this study 16 women were studied. One-fourth of the women (4) had significant spikes in their estrogen levels. When the study was submitted to the FDA, the data from two of the women with spikes was not included on the graph of the average release rates.

You can NOT average data to give you an accurate measure of a hormone level for any individual woman.

This is like saying that if you have a car on the freeway traveling at 150 miles an hour and another traveling at 50 miles that the two cars are traveling at 100 miles an hour.  If you are in the car going 150 miles an hour you are speeding!  If you are in the car going 50 miles an hour, you are probably traveling close to the speed limit.

Another example is of a man with one foot in a bucket of boiling water (212 degrees) and the other foot frozen in a block of ice (-41 degrees). You could say that on average he is comfortable (an average temperature of 85 degrees).

Each woman is unique.  If some women have spikes then that information needs to be available to women and their doctors.

Two women (Subject 11 and Subject 6) had a major spike in Estrogen within hours of insertion of the NuvaRing. The progestin level had not yet begun to accumulate in these women’s bodies, which put them at risk for a blood clot because a woman’s body needs progestin to balance the estrogen.

Two other women (Subject 20 and Subject 7) had major spikes in Estrogen later in their cycles. One at nine days and another at about 21 days.

Graph of 4 Subjects with Spikes

The heavy red line are the averages of these four women.  Averaging makes the spikes disappear!

The current graph on the NuvaRing package label shows a graph of averages.  Some women may have spikes in their hormone level and some may not.

What caused the spikes?  The manufacturer has done nothing to find out why some women would have spikes and some not.  The FDA has also done nothing.

These spikes may be one reason why some women experience serious clots while using NuvaRing, in addition to the fact that NuvaRing uses a progestin (Etonogestrel) that does not completely balance the estrogen, the risks continue.

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