Company disputes claims of 303 fetal deaths tied to birth control device
"Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure," Bayer HealthCare said as part of its 1.5-page statement. "It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term."
READ FULL STATEMENT HERE
Rep. Mike Fitzpatrick, a Republican from the 8th District in Pennsylvania, has been at the forefront of the political fight over Essure, which received FDA approval in 2002 after five years of clinical trials.
He has called on Congress to pass the E-Free Act, which would remove the product from the market.
"The FDA has received nearly 10,000 formal complaints related to Essure," the congressman said at the beginning of a telephone news conference Thursday. "Yet, even with all this, Essure remains available."
There has been a fast-growing Facebook movement with more than 27,000 women in the U.S. belonging to groups positing Essure caused them severe health problems or unwanted pregnancies.
"My once very-thick hair started falling out in clumps," Amanda Dykeman claimed during the press conference when talking about her post-Essure symptoms.
Hundreds of other women said they were forced to have hysterectomies after they had the Essure device removed.
Essure uses nickel-based metal coils to block the Fallopian tubes during a procedure that's done in a doctor's office and is considered non-surgical.
Thousands of women said after they had the procedure done, they experienced a variety of symptoms, including abdominal pain, bloating, bleeding, rashes, migraines and autoimmune problems. Roughly 700 pregnancies have been reported by women who said the procedure turned out to be unsuccessful.
Angie Firmalino, of upstate New York, spoke on the phone Thursday saying she had Essure implanted in 2009, three months after her youngest child Elijah was born. She said soon after, she started running fevers and experiencing joint pain.
"As of today, 27, 263 members are in the groups," Firmalino said. "Seventeen of those women are having surgery today to remove the device."
In its statement, Bayer HealthCare said:
"Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure. The safety and efficacy of Essure, the only FDA- approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real-world clinical experience, with the product studied with more than 10,000 women since Essure was first developed."
Fitzpatrick released a federal complaint from the Northern District of California that claimed the original manufacturer of Essure — Conceptus, Inc.— had given doctors financial incentives to push the product on patients — and even set up referral lunches between physicians and OB-GYN specialists.
Bayer reps told PIX11 News that complaint was dismissed recently after the Department of Justice decided not to get involved in the case.
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