Women are speaking out against a controversial birth control method that has reportedly caused significant health complications.
Essure, a permanent sterilization procedure that has been on the market since 2002, has drawn public scrutiny due to the severe side effects that many users said they have experienced, KMSP reports.
The procedure involves the insertion of metal coils into a woman's fallopian tubes. Tissue then grows around the coils and prevents conception. It was designed to be a surgery-free, more convenient alternative to tube tying.
Although the coils can be inserted in a doctor's office and do not require surgery, a recent study of health records in New York showed that patients who used Essure were 10 times more likely to have to undergo follow-up procedures due to ensuing complications than those who got their tubes tied, according to KMSP.
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Common health problems reported by Essure users to the U.S. Food and Drug Administration include perforations of the uterus, abnormal bleeding and allergic reactions to the metal coils. Commercials advertising the product warned that side effects may include "mild to moderate pain, cramping, nausea, vomiting, fainting, [and] vaginal bleeding."
Elizabeth Fluegge, a mother of a family of seven, told KMSP she decided to use Essure at the recommendation of her doctor. Fluegge said her health deteriorated significantly after undergoing the procedure in early 2015.
"I feel like everything's been stolen from me," she told KMSP. "I said the last 10 months have been essentially hell."
Fluegge added that she eventually had to get a hysterectomy in November 2015 because it was the only way to remove the coils from her body.
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"I don't want any more women to suffer the way I have," she said.
Bayer Corporation, the maker of Essure, has defended the procedure.
A representative for Bayer released this statement in response to public concerns over the product's safety, according to WPIX:
"At the September meeting of the U.S. Food and Drug Administration’s Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee, there was agreement among the Panel members that Essure is an important contraceptive option and the Panel provided input and guidance for the FDA and Bayer to consider. Bayer continues to work closely with FDA to assist in the safe use of Essure by women who are seeking a highly effective, permanent, non-hormonal birth control option with a non-surgical procedure."
The company insists the experiences of most Essure users show that the procedure is safe and effective.
"For the properly counseled patient, for the patient who meets the criteria, Essure is a good option," Dr. Patricia Carney, a member of Bayer’s Medical Affairs team, testified at the September FDA hearing.
As of fall 2015, more than 5,000 women have filed complaints with the FDA due to complications related to Essure use. In light of these reports, the national consumer safety organization is now conducting another review of the product, which should be completed in February, reports WPIX.
Essure patients who have suffered health problems cannot sue Bayer because the product was given "pre-emption" status when it first obtained FDA approval after a five-year clinical trial.