James F. Humphreys & Associates, L.C. has represented many people injured by medical devices, and is currently reviewing potential claims for injuries related to the Essure birth control device.
Essure is a permanently implanted birth control device which consists of metal coils that are implanted in the fallopian tubes that carry eggs from the ovaries to the uterus. Over a period of about three months, scar tissue forms around the coils, creating a barrier which prevents sperm from reaching the eggs. During that three month period, women must use other forms of birth control to avoid becoming pregnant. Because Essure is a permanent form of birth control, it is not intended to be removed.
Essure was first approved for sale in the United States in 2002, and it wasn’t long before women began reporting injuries associated with this product to the federal government. Over the next 3 years, more than 5000 women filed complaints with the U.S. Food and Drug Administration (FDA), alleging that they suffered injuries, or had unwanted pregnancies, still births and miscarriages while using Essure. Reported problems included persistent pain, perforation of the uterus or fallopian tubes, migration of the device within the body, bleeding, hair loss, and allergy or hypersensitivity reactions. In some cases, women had surgical procedures to remove the device.
In addition to filing complaints with the FDA, women began filing lawsuits asserting that Conceptus Inc. (which originally developed the product) and Bayer (which bought Conceptus in 2013) fraudulently marketed the device because they failed to fully disclose the risks associated with its use. By October, 2016, there were 3000 Essure lawsuits against Bayer, and by April, 2018, there were 16,800 lawsuits, according to regulatory reports filed by Bayer.
In response to the growing number of adverse events associated with Essure usage, the FDA took a number of steps to address this situation. Among other things, the FDA issued guidelines for labeling Essure type products in October, 2016 and in November, 2016, it approved updated labeling for Essure that added a boxed warning on packages and a checklist for patients who were considering whether to use Essure. In April, 2018, concerned that some patients were not receiving adequate information about the risks associated with using Essure, the FDA took the unusual step of restricting the sale and distribution of Essure to health care providers and facilities which properly warn patients about the risks and benefits of the device. Under the FDA restriction, patients must be informed of the risks associated with Essure, and both the patient and the doctor must sign an acknowledgement that the patient was warned of possible side effects before the device was implanted.
Since 2016, Essure sales in the United States have declined by 70%. On July 20, 2018, Bayer announced that it would stop selling Essure devices in this country after the end of the year because of declining sales. When it made this announcement, Bayer had already stopped selling Essure in the rest of the world.
Unfortunately, because many women already have Essure devices implanted in their bodies, and more women will have Essure devices implanted before the end of the year, it is likely that Essure related injuries will continue to occur.
If you or a loved one has been seriously injured by a medical device such as Essure, please call us at 304-881-0652 (local) or 877-341-2595 (toll free) for a free initial consultation. You may also contact us through our website, www.jfhumphreys.com.
Jeff Feeley & Margaret Fisk, “Bayer Essure Lawsuits Skyrocketed as FDA Pushed Stronger Warnings,” July 25, 2108, https://www.bloomberg.com/news/articles/2018-07-25/bayer-essure-suits-skyrocketed-as-f…
“Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed,” July 20, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm