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In 2002, I suffered a miscarriage while living overseas. I had only found out I was pregnant a few days before, and my husband and I were over the moon. We had told lots of people--as first-time parents often do--and then had to go through the painful process of telling people about the loss.
What made it worse was the actual physical process of having the miscarriage. No one told me it would be like labor, only without the beautiful baby at the end. Finally, my doctor scheduled me to receive a dose of Mifeprostone, which is the Czech version of RU-486. Within 24 hours, the pain was gone and I could go on with my grieving process without the accompanying searing pain. I didn't have to be checked into a hospital maternity ward--where surgical D&Cs are done in the Czech Republic--to see the women and their babies while I was mourning the loss of my pregnancy, and I didn't have to undergo anything more invasive than a routine gynecological exam.
I'm not saying that my experience means that it's safe for every woman, but it would be all to easy for forced pregnancy groups to turn this from a legitimate safety investigation into a backdoor way to make RU-486 unavailable to women who need it--whether for abortion or to complete a miscarriage already underway.
In all the headlines, it is forgotten the carrying a baby to full term also comes with risks of death. At least once every couple of years, I will see a death notice for a woman who died giving birth. Unicef stats show that in the US 12 women will die for every 100,000 live births. It's very rare these days, but it still happens. If you follow the logic that drugs like RU-486 need to be banned because there have been some deaths, then we shouldn't even encourage pregnancy because that causes death. This goes for many other drugs and medical devices. Certainly, there may be additional safety studies needed, but no doubt politics will play a large role in whatever decision is made.
Interestingly too, there are some vaccinations that cause death in a small number of people, including children, but woe to anyone that wants to suggest that they need to be studied furthered. (Some of those vaccines are for illnesses that caused few deaths in the US prior to their implementation).
I'd like to provide some context for the risks of mifepristone (RU-486 is a brand name that is not used in the U.S. market).
Mifepristone does carry a risk of death, which is very, very tiny, but if it is used by many thousands of women, it will happen to someone... and if that someone is close to you, the knowledge that the risk was small would probably be of cold comfort.
But to put it in perspective... Tylenol also carries a risk of death. It's more common than you might think to take Tylenol and then, say, a cold medication containing Tylenol, and go into liver failure. (This is Google-able if you're interested.) It kills many more people than mifepristone, although of course it is used by more people. But that only reinforces the point that the more people who use a treatment, the more adverse events we will become aware of. (Ditto for the patch. Ortho did a really big trial for approval, but not as big as the number of women who used it once it was on the market.)
As far as mortality risks, mifepristone must also be compared to the risks of carrying a pregnancy to term. It's impossible to know what would have happened to one individual woman, such as Holly Patterson, and we should assume that she would have carried safely to term had she chosen to do so (or had a safe surgical abortion). However, when we look at whether to make something available to a nation full of women, we cannot forget the mortality risk of full-term pregnancy and birth.
Then, as far as individual decision-making: It is very difficult for an individual to approach a statistic, especially with a denominator in the hundreds of thousands, and figure out what that means for her individual decision. Some people are risk-averse, others assume they will be in the uneventful majority. Still others may confront more imminent, tangible, and personal mortality risks: domestic violence increases when a woman gets pregnant and is a major cause of pregnancy-related mortality. To those women even a considerably higher risk from mifepristone might seem worth it.
Accordingly, and perhaps ironically to some, when I prescribed mifepristone, I felt like I was was often trying to drill into my patients the medical risks of medical abortion, because they were very focused on the social situation that had made them want to terminate in the first place. Of course, the social situation is right in your face and the medical risks seem (and are) very remote, so this is natural. However, it is key for safe medical abortion. In fact, the Holly Patterson story, which I followed very closely, speaks to this: she didn't tell the emergency room staff that she was/had been pregnant, and was terminating it, because of fear of people finding out. It is still the responsibility of the ER staff to determine pregnancy status, and inexcusable that they didn't do a test--even if she'd had a broken arm they should have done a pregnancy test, so they didn't give her an inappropriate medication, and it would have still been positive for up to 6 weeks after medical abortion. Nevertheless, this story speaks to what happens when the social risks seem higher than the medical ones--which is so often the case in abortion care, including surgical abortion, or in fact any pregnancy care.
So inform women of the risks, and make sure they understand them and take them seriously, but keep the risk in perspective.
Lastly, I would like to sign my name and add my credentials to this post, but I don't want to be targeted by anti-abortion forces. I've been in abortion care since 1994 and would like to continue flying beneath the radar. Thanks.