Last Saturday’s SNL, hosted by Amy Schumer, featured a much-discussed digital short on America's gun culture. (“Guns: They're here to stay!”) Personally, I enjoyed even more her Comedy Central piece contrasting the ridiculous burdens on women trying to obtain birth control, with the relative ease of buying a gun in America. Here’s the thing, though. When it comes to preventing unwanted pregnancies, the issue isn’t just about access to birth control. It’s also about the safety of the drugs and devices created to control female reproductive systems. Indeed, we’ve written about this topic many times (e.g., here, here, here, here here.) In other words, this comes up a lot. The problem, in a nutshell, is this:
Regulatory failings have had a great impact in the area of women’s health because of the number of products routinely prescribed to otherwise healthy women to control some aspect of their reproductive system. As University of Buffalo Law Professor Lucinda Finley has written, “Reproductive or sexual harm caused by drugs and medical devices has a highly disproportionate impact on women, because far more drugs and devices have been devised to control women’s fertility or bodily functions associated with sex and childbearing than have been devised for men.”
We wish things were getting better but as the saying goes, the more things change ….
It was just last month when we first learned about problems associated with Bayer’s Essure metallic birth control implant. (Just the sound of that scares me.) Writes NBC News:
The Essure implant has been sold for more than a decade and is frequently pitched to women as the only non-surgical option for permanent birth control. Manufacturer Bayer estimates 750,000 women have received the device since 2002.
But since 2013, the Food and Drug Administration has received thousands of complaints about the device from women and doctors. While the product's label warns about pelvic pain and bleeding immediately after the procedure, many women say these problems persisted and were so severe they required invasive surgery to remove the device.…
[Problems] include … chronic pain, headaches, mood disorders, hair loss and irregular bleeding. Many of those complaints have been shared through social media, including a Facebook page called Essure Problems, which has more than 20,000 members.
Incredibly, “The American College of Obstetricians and Gynecologists, Physicians for Reproductive Health, and Planned Parenthood Federation of America defended Essure,” saying, “Today, Essure is the only permanent contraception that can be performed non-surgically, allowing women to avoid potential complications associated with surgery and general anesthesia, especially those with certain medical conditions.”
Women who sought permanent sterilization through a contraceptive implant called Essure were 10 times as more likely to be back for surgery within a year than women who had their tubes tied, according to a new study of 52,326 women sterilized in hospitals and ambulatory surgery centers in New York State from 2005 to 2013.
The findings add to growing concerns about the device, which has been on the market for over a decade. Thousands of women who claim they have been hurt by it have urged the Food and Drug Administration to warn the public about potential complications and pull the device from the market. …
“This study is important because it looked at Essure women in the real world, not the more ideal world of clinical trials,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group. “The very high rate of reoperations — 10 times as high with Essure — is likely to add to concerns about the accuracy of the clinical trial data provided to the F.D.A.” when the device was approved.…
Since the device went on the market 13 years ago, the F.D.A. has received more than 5,000 complaints about serious complications, including severe back and pelvic pain; painful intercourse; heavy, prolonged menstrual bleeding; chronic fatigue; autoimmune diseases. It has also received reports that the device’s coils have pierced the fallopian tubes and lodged in organs, leading to hysterectomies and other surgeries. Bayer officials have said repeatedly that the device is safe and that the complications are in line with those from surgical sterilization.
Yet, “Some experts familiar with Essure said the new study may have underestimated or failed to capture all of the complications related to the device.”
What a disaster. Your move, Amy Schumer.