But thousands of women have attributed other problems to the implant, including some not listed on the warning label: chronic pain, fatigue, weight gain and depression. The Company said that they greatly sympathize with women who faced difficulty in using Essure and gives highest priority to the safety of their patients.
Women who say they have been harmed by Essure permanent birth control called on the Food and Drug Administration to recall the device Thursday.
Bayer’s contraceptive device, Essure, will be reviewed by U.S. health experts later this week, following an increasing number of complaints over potential Essure side effects. Thousands of women say Essure has caused them serious health problems, including one woman from the valley.
The USA regulatory agency said it has found over 20,000 complaints that women have shared with others on a special Twitter and Facebook page. She said she felt like she “woke up from a 5-year flu” when the birth control implant was taken out.
Bloating, chronic pelvic pain, severe rashes, extreme bleeding and auto-immune disorders are included in the complaints.
Around 750,000 women use the device and many suspect the nickel metal causes the side effects.
Essure is a permanent birth control method wherein soft coils are inserted into the fallopian tubes to induce tissue to grow around them, thus blocking the sperm cells and preventing them from getting to the egg.
The FDA noted in its briefing materials for Thursday’s hearing it was aware of the allegations from women that records had been altered, but said its monitoring of the study showed no evidence of that.
“I was extremely sick, I would bleed all the time”, says Taylor. An emergency room nurse in New York, Mendez said she liked the idea that she could return to work after a quick, in-office procedure.
Later that year, on November . 14, Hudak called to report she had been bleeding after intercourse for the past two months, and the clinic note says Bradley referred Hudak to “her regular gyn”. “Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the Panel’s advice”, said Dario Mirski, M.D., vice president and head of USA medical affairs at Bayer. In preparation of Thursday’s meeting, Southern Med Law has learned that the FDA posted 90-pages of information containing questions for its Advisory Panel and has set aside time to receive comments from the public to express Essure problems.
“I’ve had no problems”, she said. “And I think that is the light for me at the end of the tunnel for the women who are now coming forward, the doctors are actually welcoming them with open arms and they’re listening”.
“The FDA takes reports of safety concerns seriously”, the agency said in a statement. Others do not include a comparison group of patients who have not received the device, a critical component of quality medical research.