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York women among group fighting to remove Essure
Tiffany Bathgate was told by her gynecologist that Essure was her best bet for permanent sterilization after she had determined another pregnancy would be hazardous to her health.
The small, flexible coils designed to block ovarian eggs from reaching the uterus were inserted into the Dallastown resident's fallopian tubes in November 2010, and she says she has had consistent pain ever since.
Bathgate, a 31-year-old mother of two, said her symptoms include heavier menstrual periods, pelvic swelling, pain during intimacy and an internal cyst.
"At the time, there were no negative reviews online," she said. "I was never told about the side effects. If I had more info from the doctors, I might have made a different decision."
Strength in numbers: Bathgate is now one of more than 27,000 women actively participating in the Facebook group, Essure Problems, whose cause has been taken up by Republican Congressman Mike Fitzpatrick, who represents Pennsylvania's 8th Congressional District.
Fitzpatrick introduced the E-Free Act in the House in November 2015 to require the U.S. Food and Drug Administration to remove its approval for Essure, which has been FDA-approved since 2002.
During a conference call Wednesday, Fitzpatrick said he's been told no similar bill to forcibly retract FDA approval from a medical device has ever been filed in Congress.
"I'd prefer the FDA react on their own," he said. "But if the FDA won't, Congress must act."
Fitzpatrick has been questioning FDA regulations for more than a year, first getting involved when some of his constituents approached him about problems with a separate medical device, he said.
FDA issues: The Congressman recently partnered on this issue with a York County woman who used to work at the FDA.
Madris Tomes had been working with the FDA's adverse medical device reporting system, which is responsible for storing patient, doctor and manufacturer reports of adverse events related to medical devices.
Tomes said she recognized major issues with the system's analytics, but the FDA ignored her recommendations, so she left. She has since created her own company, Device Events, which uses public FDA data with Tomes' improved search functions.
Tomes and several women associated with Essure Problems recently used Device Events' improved search functions to identify a major discrepancy with the FDA's reports on Essure.
According to the FDA's investigation, it had received 5,093 medical device reports related to Essure as of May 31, 2015, and those reports included five fetal deaths.
Tomes revealed Wednesday that she had found 303 reports of fetal deaths related to Essure. The issue, she said, is that device manufacturers must check one of three boxes when filing the reports: death, serious injury or malfunction.
The majority of the 303 reports were filed as serious injury or malfunction, Tomes said. Her system was able to identify the fetal deaths in the report's "Additional Manufacturer Narrative" section, which is not easily searchable using the FDA's current system.
FDA and manufacturer response: Fitzpatrick sent a letter to the FDA's director of the Center for Devices and Radiological Health urging the administration to consider Tomes' findings.
FDA spokeswoman Deborah Kotz wrote in a statement that the administration received Fitzpatrick's letter and will respond to him directly.
"Ensuring the safety of Essure is a high priority issue for the Agency," Kotz wrote. "We are working expeditiously to conduct an evidence-based review of all available information to inform what future actions may be in the best interest of women using or considering Essure."
Kotz added that the FDA has only banned one device in the past 10 years, but it has issued numerous device recalls.
Tara DiFlumeri, a spokeswoman for Bayer, the German-based manufacturer of Essure, wrote in an email that more than 1 million of the devices have been distributed worldwide since 2002, with the majority distributed in the U.S.
"We have reached out to many women who have reported complications, listened to their experiences and provided any guidance we can," DiFlumeri wrote. "However, there are risks with all medical procedures, drugs and devices, and the communication between a woman and her physician is critical for understanding and navigating these risks."
No compensation: Bathgate and other women in the Essure Problems group have said their doctors would often discount the notion that Essure was causing serious issues.
"The doctor said my body was just getting used to the device," said Angie Firmalino, who started the Facebook group in 2009.
Many of the women have since had hysterectomies to remove the device, but Bathgate still has it implanted because she lost her health insurance shortly after the initial procedure, she said.
"I'm just tired a lot, not as active as I used to be," Bathgate said of her life the past few years. "My husband and I, our intimacy is just not the same, it's too painful."
Bathgate said she's also racked up a few medical bills due to emergency room visits when the pain got too severe.
Under current federal law, Bathgate and others aren't allowed to file lawsuits against Bayer because it made it through the FDA's Premarket Approval process.
Fitzpatrick has also proposed an amendment to remove that law.
"The assumption is that the FDA is protecting the safety and wellness of our citizens by fully reviewing devices before they go on the market," Fitzpatrick said. "The systems in place are outdated, and we have an obligation to fix it."
— Reach David Weissman at email@example.com.