Washington D.C., Nov 5, 2015 / 03:01 am
A Philadelphia congressman is sponsoring a bill that would pull an FDA-approved birth control device, Essure, off the market.
U.S. Representative Mike Fitzpatrick, a Republican from Levittown, introduced a bi-partisan bill called the "E-Free act" to Congress on Nov. 4. The new bill would ban the Essure System because of its various adverse side effects in thousands of women who have had the device implanted.
Essure, manufactured by Bayer and granted pre-market approval status by the FDA, is a type of permanent birth control in the form of flexible, nickel-titanium coils that are non-surgically inserted into the fallopian tubes. Once there, the coils create a chronic infection, causing scar tissue to form and effectively closing the tubes and rendering the woman sterile.
So many women have complained about adverse side effects of the device that they have formed their own Facebook group, "Essure Problems." There, more than 23,000 women who have dubbed themselves "Essure Sisters" come together and log complaints about chronic pain, allergic reactions, perforated organs, migrating coils, and fetal disfigurement caused by the device.
"I feel like my children have lost their mother for the last 3 years. I now have chronic pelvic pain, back pain, major hair loss, very painful and heavy menstrual cycles, dental issues, aches all over my body, extreme fatigue and depression. As a single, hardworking mother, all I can do is push forward through all the pain," reads the testimony of one "Essure Sister."
To date, at least five fetal deaths have been caused by Essure in women who became pregnant after having the device implanted, and the deaths of at least four women have been attributed to the device. The FDA has received over 5,000 formal complaints against the device.
Hundreds of women have also called in to Fitzpatrick's office with Essure complaints, prompting him to sponsor the bill, which gets its name from the women who have the device removed and declare themselves "E-free."
"The failures of Essure are well documented and wide ranging. Yet, in the face of all these facts, this device remains on the market; certified with the FDA's stamp of approval. That's unacceptable to me and unacceptable to the tens of thousands of 'Essure Sisters' who are living with this device's effects," Fitzpatrick said at a press conference Nov. 4.
"If the FDA or manufacturer aren't willing to act in the best interest of these women, Congress must."
Essure has been on the market since 2002, when it was manufactured by the medical company Conceptus. When Bayer acquired Conceptus in 2013, it continued to distribute Essure.
Bayer contests that the device's safety is backed by more than 10 years of research.
"Bayer stands by the positive benefit-risk profile of Essure and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee," Bayer spokeswoman Tara DiFlumeri said in a prepared statement.
"Bayer's highest priority is patient safety and we sympathize greatly with any woman who may have experienced problems following an Essure procedure."
When it was pre-approved by the FDA in 2002, the FDA used clinical trials from Conceptus, the company which would profit from the approval and sales of the device, to determine whether or not it was safe for women.
When asked if this process created a conflict of interest, the FDA told CNA in February: "Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective."
Desa-Lynch and the administrators of Essure Problems told CNA that they have three full sets of records from the clinical trials that show complaints of abdomen pain in women in the trial being marked off as "unrelated," along with other altered information.
Dr. Shawn Tassone is an Ob/Gyn who used to implant Essure devices in his patients, but has stopped since receiving multiple complaints from patients.
Dr. Tassone has also seen the clinical trials, and said there are times when the ages of women with complaints or complications are crossed off and altered in order to better fit the picture that Conceptus wanted to portray.
"The clinical trials that they were basing their information on were falsified, and we've brought this to the FDA," Desa-Lynch said. "They (the FDA) just say, 'upon their investigation they find everything to be safe, they find the benefits to outweigh the risks'."
The fight to remove the Essure device from the market even prompted the "Essure Sisters" to enlist the help of Erin Brockovich, the legal clerk and environmental activist made famous by the 2000 film about her life.
In the past few months, the group has made some headway with the FDA, which in June updated the risks of the Essure device to include symptoms from the filed complaints. In September, the FDA conducted a hearing regarding Essure, but no recommendations have yet been submitted to the full FDA.
"The Essure Problems group is so very grateful for the support of Congressman Fitzpatrick. The women harmed represent every party, every nationality, every color, and every walk of life. We have been able to stand side-by-side and unite and work together for this cause," said Amanda Rusmisell, victim and Legislative Liaison of the Essure Problems group.
"Tens of thousands of otherwise healthy young women have been significantly harmed by the medical device Essure – most of them requiring multiple surgeries, most often, hysterectomy. We are asking Congress to help push the FDA to revoke the approval for this dangerous and ineffective medical device."