The device is inserted into the fallopian tubes, and after some time, tissue grows around it and blocks the way to prevent sperm cells from reaching the egg cell.
Advertisement
Users are also warned that the birth control implant may slip out of its position and enter the user’s pelvis or lower abdomen, following which a surgery might be needed for removing the device.
The implant device was approved by the Food and Drug Administration back in 2002. At the hearing, a Bayer representative said the company will present the benefits of Essure, including that it is non-surgical, non-hormonal and may be available at no cost to those with health insurance.
Dr. Patricia Carney, the organization’s medicinal executive for Essure, said the organization respects the talk. The FDA will not ask the panel whether it should be pulled from the market, however. “We need to know whether there is a connection to the item”.
Meanwhile, some experts say it’s not as effective at preventing pregnancy as advertised: A 2014 study in the journal Contraception estimated that up to 9.6 percent of women sterilized with Essure could become pregnant within ten years, versus 2.4 to 4 percent of women who got their tubes tied laparoscopically (a.k.a. tubal ligation).
“The FDA takes reports of safety concerns seriously”, the agency said in a statement.
Another woman, 28-year-old Angela Lynch, said she initially dismissed the symptoms she felt as experiences related to her recent childbirth but later on realized they were not. “After two years I started losing hair”.
Angie Firmalino, one of the administrators on the Essure Problems Facebook page and a former Essure patient, told ABC15 Wednesday that there will be about 60 women who have been injured by Essure at the meeting.
Lynch eventually had Essure removed and had a hysterectomy instead.
Among the problems pointed out by women using Essure were depression, heavy bleeding, and allergies and other “unlisted symptoms”.
Advertisement
Basinski, who practices in Newburgh, Indiana, said she in “no way discounts the patients out there recounting their experience”, but said it was not possible to draw scientific conclusions from anecdotal information.
