Regulations needed to stop dangerous telemedical “medication” abortions — Part I

Chemical abortions are difficult and dangerous

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

Editor’s note. The issues raised here in this series are part of a larger more detailed defense and analysis of the FDA’s regulations on mifepristone offered in National Right to Life’s “Special Report” found at www.nrlc.org/uploads/reports/RUREMSDefenseReport.pdf .

Holly Patterson had just turned 18 and was working to earn money for college. The first time her father heard that she was pregnant and had taken the abortion pill was when he was called to the hospital and found her hooked up to a ventilator. She died later that day when a rare infection overwhelmed her body.

Orianne Shevin was a 34 year old attorney, a mother of two. The same rare infection that killed Holly Patterson two years before took Shevin’s life in June of 2005, shortly after she had taken the same abortion pill.

Rebecca Tell Berg, a 16 year old Swedish teen, collapsed and bled to death in her boyfriend’s shower after receiving the abortion pill at her local hospital. 

Manon Jones, another teenager from Britain who took the abortion pill, died on a gurney in a hospital hallway in Bristol, England, waiting for a transfusion.

Brenda Vise, a pharmaceutical representative from Chattanooga, Tennessee, died when an ectopic pregnancy missed by the abortion clinic ultrasound ruptured. Staff at the clinic thought she was just experiencing the normal cramps and bleeding that accompany a standard chemical abortion.

Those are just a few of the names of the women who died or suffered “complications” after having taken abortion pill advertised as “safe and effective.” 

A 2018 document from the U.S. Food and Drug Administration (FDA) tells that there have been at least 24 known deaths associated with use of mifepristone, the abortion pill. (This is the most recent national data:  https://www.fda.gov/media/112118/download)

That same document tells us there were nearly 100 ectopic pregnancies like Brenda Vise’s.  The abortion pill, RU-486, doesn’t work in circumstances of ectopic pregnancy. 

And it tells that thousands of others have faced significant, potentially deadly “adverse events” or complications similar to the ones encountered here – infections, hemorrhages, rupturing ectopic pregnancies, and more.

Even when they work, these abortions are bloody, painful, time-consuming… and complicated.

The popular image of the drug induced chemical abortion as a relatively quick, easy, and painless procedure is at odds with the medical record and the experience of women who have actually taken the abortion pills.

The standard chemical or “medical” abortion, even when successful, involves several steps. Not one, but two drugs are taken, multiple pills ingested over a period of a couple of days which involve substantial pain and bleeding that may take weeks to be complete.

To be used as safely and effectively as possible, women should be screened to make sure they are not over the gestational limit, do not have an ectopic pregnancy, and have no allergies or conditions that would make the pills ineffective or dangerous.

Once a patient has been identified as an acceptable candidate for chemical abortion, a healthcare professional should instruct them as to the proper use and timing of the pills and counsel them on how to recognize signs of infection or abnormal bleeding that may require emergency treatment. The importance of a follow up assessment to determine “success” of the abortion is to be stressed since “prolonged heavy vaginal bleeding” is not proof of a complete abortion.

The process will not be over quickly. Unlike surgical abortion, which may be completed in five to ten minutes, abortion pills take time to do their deadly work. The first drug, mifepristone, shuts down the support system sustaining and protecting the developing embryo. The second drug, misoprostol, taken a day or so later, stimulates powerful contractions to expel the emaciated corpse.

Heavy cramping and bleeding are standard parts of the process and may continue on for days or even weeks, perhaps long after the baby has passed.

While the abortion is happening, it may involve many anxious and uncomfortable moments where a woman is trying to determine whether the amount of pain she is experiencing and the amount of blood she is losing are normal or signs of something gone wrong.  She may find it psychologically challenging encountering and disposing of her aborted child.

A chemical abortion which is “painful, messy, and protracted,” as TIME magazine described it during U.S. trials of mifepristone in 1994, is hardly unusual. If anything, it has proven to be the norm.

They don’t always work. And that can be a problem.

Even used within the framework set by the FDA, the medical abortion protocol has a significant failure rate.  According to the FDA’s “Medication Guide” provided to patients,

About 2 to 7 out of 100 women taking Mifeprex will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.

For those who wish to continue what they started, failure means, at a minimum, more medications, more waiting, and the possibility of a trip back to the clinic for the surgery they wished to avoid in the first place, along with all its risks.

Those are not insignificant numbers.  We do not know exactly how many women attempted these abortions in 2017, but we do know that there were 339,640 chemical abortions recorded that year by the Guttmacher Institute. If these represented only the “successful” abortions, a two percent failure rate that year would have meant incomplete or failed chemical abortions for 6,931 women; seven percent would be 24,260. 

If growth in the number of chemical abortions has continued since 2017, the numbers would be higher still.

Failure rates increase as gestation increases

Failed and incomplete abortion may be a problem for even more women. Abortion providers publicly are advertising a willingness to perform these abortions at gestations beyond those specified on the FDA label. In addition, the abortion industry is now pushing telemedical or “no-test” self-managed abortions where the mother’s gestational age may never be clinically ascertained.

Again, failure of the drugs means, for many of these women, surgery to complete the abortion or to stop the bleeding. 

High failure rates provide an additional source of anxiety for women having chemical abortions who may be uncertain if her dead baby has passed. Some women may see their baby and have a clear sense that the abortion is over, though bleeding may continue for several days. but others may cramp and bleed and pass clots without identifying that it is the baby’s remains. 

It is entirely possible to think one has aborted when one has not, or to think one has not and find out later one has. Absent some clear visual confirmation, an especially sensitive pregnancy test or a professional examination, some level of uncertainty is entirely warranted.

The problems with chemical abortion had to be addressed.

The FDA knew of many of these risks, the inherent complexity of these abortions, the high failure rate associated with these abortion pills before it ever approved the drug. 

This is the reason why its original approval came with significant guidance and regulation, why it has continued to monitor the drug’s performance. That is why, in light of that accumulating record of deaths, injuries, and failures, the FDA chose to keep in place and reinforce these limitations in the years that followed.

More on that tomorrow in Part II.