Birth control controversy: Local women join Facebook group for support
CINCINNATI (WKRC) - A recent decision by the Food and Drug Administration to keep a permanent method of birth control on the market is creating quite a controversy.
Those in favor, think it's an option women should have to prevent pregnancy. Those opposed say the risks outweigh the benefits for women.
It's been on the market for more than a decade, a method of birth control is called “Essure.” It simply involves implanting coils into the fallopian tubes. Eventually, scar tissue forms around them to block pregnancy. But after woman began reporting some serious health problems from it, the FDA made the decision to review it. They concluded it will stay on the market and those who support the decision say new warning labels and a checklist for those considering it is enough to let women know the benefits and the risks.
Those who oppose that decision and who are part of a Facebook group called “Essure Problems” say the FDA did not go far enough.
Melissa Chestnut, a member of that Facebook group, said, “I had Essure implanted in 2008, I thought less down time, great choice for me and my life at the time.”
Melissa, Erin, Ashley, and Jenny are all members of “Essure Problems.” Melissa says she found the group researching her own symptoms.
“After seeing 20 some thousand ladies reporting similar things to me that told me that that was probably a big part of my issues.”
New labeling for Essure will now require several potential risks from the device to be listed for women including persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.
But the women Local 12 News talked to that are member of “Essure Problems” say the FDA has not gone far enough.
Ashley Branton said, “I’m scared, let’s put it that way, not to mention this is supposed to be permanent.”
Erin Brennan said, “I would like to see it recalled, honestly.”
Melissa, Erin, and Jenny say they have all expressed these concerns to the FDA, which during the review and now does invite women to share their thoughts and comments. The “Essure Problems” Facebook group now has nearly than 32,000 members.
According to medwatch.org, they are not alone in some of what they say they've experienced with Essure.
Jennifer Lawrence said, “Since 2002 there have been 10,000 reported injuries to both women and babies as the result of the Essure devices.”
Lawrence is a medical malpractice attorney who also met up with Local 12 while talking to the women. She does not represent anyone in the Local 12 News story but does represent other women who have filed suit against Bayer, the manufacturer of Essure.
“These women deserve compensation, fair and just compensation because these medical device manufacturers and corporations are making billions selling these devices when they've known of the risk and they haven't properly warned women of the risk associated with the devices,” said Lawrence.
A few months ago the FDA announced, after reviewing the complaints and complications reported to the FDA, the decision was made: Essure would stay on the market.
It's a decision with which Dr. Jim Whiteside, a women's health specialist who does not treat any of the women in the Local 12 story, agreed with.
Dr. Whiteside said, “To take it off the market would be denying a lot of women a very effective, in many cases sometimes life changing, treatment.”
Dr. Whiteside is getting support from another physicians in the area.
The fda declined Local 12’s request to go on camera, but in their final guidance on Essure did agree that they now want to help, "ensure more informed decision making among women considering these devices.” They will now require new warning labels on Essure and a checklist for women considering the device. It will address some of what Jenny reported in her complaint she has experienced. That includes chronic pain and allergies to nickel.
Dr. Whiteside said, “The outer coil is made up of stainless steel and a polyester type material that is supposed to induce tissue ingrowth and then there's this nitinol inner ring which is a nickel titanium alloy.”
Jenny said, “I believe that's why I am having so many problems, I am allergic to nickel and I always have been.”
Bayer also declined Local 12’s request to go on camera but sent a statement saying, “Safety and efficacy of Essure is supported by more than a decade of research," and "patient safety is our top priority."
They also say the new labeling now required is in the works. It will provide a "boxed warning" and a "patient decision checklist" so patients can make an "informed decision along with their physician" prior to the use of Essure.
They also referred Local 12 News to Dr. Amy Brenner to speak on their behalf. Dr. Brenner is an obstetrician gynecologist who does not treat any of the women in this story. Dr. Brenner not only does offer the method of birth control to her patients, bbut when she was looking for permanent birth control for her own use she went with Essure.
“I ended up doing Essure, and it’s been great,” she said.
Dr. Brenner says her advice to all women she counsels about birth control is that, “Other than abstinence every form of birth control has pros and cons with it and Essure is no different.” She continued, “I think the message here is you have to have an in depth conversation with your doctor about the pros and cons of every birth control method out there, even non-surgical methods such as birth control pills.”
Essure can be removed, but Jenny, who Local 12 talked to several months later again after the initial interview, chose instead to remove it by having a complete hysterectomy.”
Following her surgery, she says she felt better almost immediately.
As for what she wants women to know about Essure?
“I think it should be banned. I don't feel it’s safe, especially knowing how much better I feel without it in my body. It should be banned.”
More than 2,000 women have reported to “Essure Problems” that they have had surgery to remove it since the FDA began reviewing the device in September 2015.