Leslie Rhode/KXAN Special Contributor
Published: May 17, 2016, 9:00 pm Updated: May 17, 2016, 11:03 pm
AUSTIN, TX (KXAN) — Essure, a permanent birth control device, is under scrutiny by the Food and Drug Administration after thousands of women have complained of long-lasting painful effects they say are related to the birth control. The manufacturer, Bayer, estimates about 750,000 women are using Essure, and most of them are in the United States.
After Angela Otwell delivered her second child, she thought long and hard about whether or not she wanted a permanent form of birth control. She says her last pregnancy had complications due to an autoimmune condition, but she claims those health challenges cannot compare to the physical and emotional pain she has endured since she got Essure.
The Belton mom was only 28 years old when she had the birth control device implanted in January 2015. Five months later, she had an ovarian cyst rupture she blames on her birth control.
“Ovarian cysts just feel like someone took a very long metal rod that’s sharpened at the end and takes it and skewers it through your body wherever it is,” said Otwell.
For Otwell, the most frustrating part of her life now is the constant fatigue. She says she has lost a great deal of weight and energy since the day she had the permanent birth control implanted. With two young children still not in school, she says she feels so guilty not being the energetic mom her two children deserve.
“I go to the grocery store and that’s about it. I really want a shot at being a mom. I dream of taking the kids to Disney World or, you know, hiking. I just hope I get that opportunity.”
Atwell isn’t alone.
Felicia Crossland lives with fatigue and pain which she also claims was caused by Essure. The Liberty Hill mother loved the idea that the permanent form of birth control did not require anesthesia and down time like having her tubes tied would, so she opted for the devices after her second child. In the years since, she says she often suffers bloating and severe menstrual pain. By the end of most days, Crossland claims the pain becomes too much to bear.
“What happens most nights is there’s this incredible pain that builds in my pelvis and works its way down in my legs,” explained Crossland. “I would like to say it’s something as simple as a pinched nerve, but I really don’t think it is.”
How Essure Works
Doctors insert the small Essure devices into the fallopian tubes through the cervix. Within three months, scar tissue grows around the coils creating a barrier that prevents sperm from reaching the eggs. According to the company’s website, most women go home 45 minutes after the procedure.
Patients are supposed to go back to the doctor after three months for a confirmation check to make sure Essure is working properly to prevent pregnancy. The manufacturer’s website warns women to use other forms of birth control until they pass the confirmation test. Essure marketing indicates the product is 99 percent effective at “permanently preventing pregnancy.”
The Essure coils are made of materials that include a nickel-titanium alloy, a material used in other medical devices like heart stents. The packaging warns patients with nickel allergies may experience an allergic reaction with symptoms like rash, itching and hives. The coils do not contain hormones.
Essure was approved by the Food and Drug Administration in 2002. At the time, the birth control was manufactured by Conceptus, Incorporated. Bayer acquired Conceptus in 2013. Essure received the FDA’s most stringent review before it was marketed and Conceptus was required to conduct two post-approval studies.
According to FDA records, approximately 10,000 complaints have been filed complaining about health complications related to the use of Essure. Records show most women reported pain/abdominal pain, menstrual irregularities headaches and fatigue. The agency says some people reported more than one problem.
The FDA’s website states, “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”
On Sept. 24, 2015, the FDA held hearings on the growing number of complaints regarding the adverse effects of Essure. Doctors and patients testified about their experiences with the permanent birth control device.
After the hearing, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks. The agency also drafted a boxed warning to make sure a woman knows the risks associated with the product and a patient checklist that doctors review with a woman to make sure she understands the benefits and possible health complications.
Bayer still claims the birth control option is safe for most women and the benefits outweigh the risks.
“The data around the safety and efficacy of Essure has been examined in the company and by the FDA, and the data does not support taking it off the market,” said the Director of US Medical Affairs, Women’s Health Bayer, Dr. Patricia Carney. “Even in the latest statements from the FDA–for the majority of women– essure is a good option.”
The FDA took public comment on the draft box warning and patient checklist for 60 days. That period ended on May 3, 2016.
A bipartisan group of U.S. lawmakers introduced the E-Free Act (H.R. 3920) on Nov. 4, 2015 in hopes of pulling Essure off the market. The bill would require the FDA to withdraw its approval of the permanent birth control.
Living with the Pain
Angela Otwell and Felicia Crossland both say they do not blame their health problems on their doctors who implanted Essure, but rather the device itself.
Otwell and Crossland say they have contacted a new physician who has agreed to remove their birth control devices. Because of the way Essure coils are implanted, the women say the coils cannot be removed without a complete hysterectomy, which is the removal of the uterus.
Both women are waiting on the wording of the FDA’s final boxed warning of Essure, but both wish it would just be removed from the market altogether. There has been no action on the E-Free Act in Washington, D.C.