Birth Control Legal News Articles & Interviews

Santa Clara, CA On the ”Essure Problems” Facebook Page, which was started in 2011, Angie Firmalino advises about 44,000 women, called E-sisters, not to discuss their settlement as it comes with a confidentiality agreement that includes “restrictions about discussing your settlement online… discussing your settlement will jeopardize it.” Ms. Firmalino, who started the group, is referring to the $1.6 billion Bayer is paying to thousands of women who said they have suffered severe, long-term health problems from Bayer’s Essure birth control implant.

Santa Clara, CA Almost two years after Bayer stopped selling Essure in the U.S., and four years after the FDA told Bayer its birth control device needed a black box warning regarding potential serious side effects, the pharma giant will pay $1.6 billion to settle Essure lawsuits brought by nearly 39,000 women in the U.S. who suffered serious health complications as a result of Essure fallopian tube implants.

Bayer says it will no longer sell Essure in the U.S. due to decline in sales. Bayer doesn’t say, however, that its decision comes after the FDA threatened the drug giant with civil and criminal penalties if it didn’t warn patients about adverse Essure side effects.

York, PA: Last month a group of women, including "Essure Problems" Facebook representatives and Madris Tomes from Device Events, met with FDA chief Scott Gottlieb in an attempt to have the Essure sterilization device withdrawn from the U.S. market. At the meeting, Tomes presented data from the FDA's own MAUDE ((Manufacturer and User Facility Device Experience) database that the FDA and their legal counsel in attendance were seemingly unaware of. One would think the FDA may be embarrassed being caught off-guard like this, to say the least.

Washington, DC. Essure critics last week met with FDA chief Scott Gottlieb to discuss problems with the sterilization device, particularly Bayer's failure to warn of Essure's serious complications. But Gottlieb said they need to wait for Bayer to finish its safety study - in 2023! Perhaps those critics should have brought to the meeting lawyers, guns and money.

Jefferson City, MO:A St. Louis Circuit Judge in 2016 ruled that an Essure lawsuit filed by 92 women against Bayer could proceed in Missouri, but now that may not be the case. All the plaintiffs claimed they suffered injuries after having the permanent birth control device implanted, and they contended that Bayer is subject to jurisdiction in this state because it does business, generates revenue and conducts marketing for Essure in Missouri.

Toronto, ON. Nickey followed her doctor’s orders, and the Mirena manufacturer’s orders: five years after the IUD was implanted, she made an appointment to have it removed. But it wasn’t that easy. Next month will be the fourth, and she hopes final, attempt to have all of the birth control device removed from her uterus.


“On the first attempt, my OB/gyn couldn’t find the string so he sent me to another specialist where I had an ultrasound to see where exactly this Mirena was,” says Nickey. “He found the Mirena in my uterus—where it was supposed to be—but when he tried to remove it, the metal piece broke.”


Next up, Nickey had to undergo a general anesthetic, but her doctor told her during the follow-up appointment that the Mirena had perforated her uterus. “He told me that a Da Vinci surgical robot was supposed to have been used in this procedure but it wasn’t available that day,” Nickey says. he didn’t tell Nickey when and how her uterus was perforated by the Mirena. “He is definitely going to use the robot next month to retrieve this broken piece— it will be the fourth attempt to have this Mirena entirely removed.”


A study published by the International Journal of Women’s Health concluded that IUD perforation, “is a rare but serious complication of IUD use”. If a device perforates the uterine wall, it can continue to migrate elsewhere in the body and extensive surgery may be necessary to repair the damage. Nickey is 33 years old and the mother of a 10-year-old boy. She wants to have another child, so this complication is extremely worrisome.


Given the number of lawsuits filed against the manufacturer, Bayer Healthcare, alleging permanent injuries and trauma due to complications that necessitated surgical removal, IUD perforation is not so rare. (The study was conducted in 2014). Between 2000 and 2013, the FDA had received 70,072 complaints about the Mirena IUD, according to a report by
7 Action News investigators. (Here is the FDA’s adverse event reporting system, called FAERS.)


“Since the first surgery to have the Mirena removed I have had such heavy bleeding that I needed to take iron pills and often found myself shaking,” says Nickey. “As well, I had a lot of pain after the surgery—I’m not looking forward to the surgery on January 24th. And it’s a one-hour drive to the hospital. Who is paying for my time?

“If I knew what I know now about Mirena, I would never have gotten this IUD. I’m weighing my options about other kinds of birth control but before that, I have to get my body back to normal. And I am concerned that I have damage to my uterus because I want more kids one day. My doctor knows I want more kids and he has given me options if it cannot be removed. If push comes to shove, he mentioned hysterectomy. Emotionally and physically, this IUD has taken a lot out of me…I just want it out.”


If the Mirena has perforated the uterine wall, robotic surgery or laparoscopic surgery is necessary. A number of women who have undergone surgery to have the device removed have charged Bayer with manufacturing a defective product. They seek damages to cover medical expenses, lost wages, and ongoing care needs, and to compensate them for pain and suffering. Sadly, many women have also undergone hysterectomies.

Moline, IL: To give some idea of the damage Essure has done, Amanda’s support group—Essure Problems-- has grown from 250 women when she joined to over 35,000 members. “We have physicians visit our Facebook page, telling us they once implanted the device and are now trying to perfect their removal technique,” she says.

Oakland, CA: The next twelve months will be critical for Mirena IUS (Intrauterine System) contraceptive plaintiffs currently engaged in a Multi-District Litigation lawsuit against Bayer alleging the hormone coated device leads to an intracranial condition with the potential to cause permanent blindness in some users.

Decatur, IL: Litigation involving Essure is taking its toll on Bayer. In less than a year, the permanent birth control device manufacturer has seen lawsuits more than double, and it has been removed from every global market, except in the U.S.