FDA is expected to announce the results of its investigation
FDA Announced The Results Of Its Investigation Into Essure. The Food and Drug Administration (FDA) is expected to announce the results of its investigation into Essure, a permanent form of birth control. Thousands of women are advocating that the device is dangerous and should be pulled from the market.
Amanda Dykeman of Coal Valley, Illinois is one of those calling for Essure’s removal from the market, according to television station KWQC. Dykeman says she experienced life-changing side effects with the device. “My hair was falling out, I had bloating out to where I looked 8 months pregnant, I was tired all the time,” Dykeman said.
‘Essure’ is a permanent form of birth control, marketed as a non-surgical alternative to standard laparoscopic sterilization surgery, which is done with small incisions. The ‘Essure’ device consists of a small pair of metal coils that are inserted into the fallopian tubes to create scar tissue that blocks the tubes and prevents pregnancy. ‘Essure’ can be inserted in a procedure in a doctor’s office.
But women implanted with Essure have reported complications including pelvic pain, painful sex, organ perforation, device migration, metal allergies, unplanned pregnancies, and ectopic pregnancies, which can be life threatening if not detected early. “Just over the last two years we’ve tracked over 4,000 device removal surgeries,” Dykeman said.
Woman Claimed Adverse Effects From Essure
Enough women came forward claiming adverse effects from ‘Essure’ that in 2015 the FDA opened an investigation. In September 2015 the agency convened the Obstetrics and Gynecology Devices Panel to gather scientific and clinical information about ‘Essure’ and to hear women’s accounts of their experiences with the device.
Members of the online group ‘Essure’ Problems spoke to the panel. Dykeman, an administrator for Essure Problems, presented evidence that Bayer falsified clinical trial records to get the device approved. Original participants in the Essure trials came forward and said their responses to questions about complications were falsified.
Dykeman has been an advocate for removing Essure from the market. She says every day new women come forward to share their stories. Dykeman worries that the FDA will not take serious action on ‘Essure’, but will give Bayer, Essure’s manufacturer, “a slap on the wrist,” according to KWQC.
If the FDA does not withdraw Essure’s market approval, the group plans to continue to push for change. The group has already approached Congress with their concerns and Rep. Mike Fitzpatrick of Pennsylvania introduced the E-Free Act, legislation that would require the FDA to withdraw ‘Essure’ from the market.
Though Bayer maintains that a decade of use has demonstrated that ‘Essure’ is safe and effective, some doctors have stopped offering the device to patients until the FDA’s findings are released. “We need to re-evaluate what we can do to make something work in the future,” Dykeman said, KWQC reports.
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