Major issues with birth control device

When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilisation procedure that could be done in a doctor's office in just 10 minutes.

Now, 13 years later, thousands of women who claim they were seriously injured by the implant are urging the Food and Drug Administration to take the device off the market and to warn the public about its complications.
Troubling long-term data on women using the device, called Essure, were published on Friday after an unusual eight-year delay. Several patients have filed lawsuits against Bayer HealthCare Pharmaceuticals, and representatives of patient groups plan to meet with officials of Bayer, the manufacturer, on Tuesday to discuss their concerns.
The device is a small metal and polyester coil placed into a woman's fallopian tubes in order to make her permanently sterile. The FDA approved Essure after a fast-track review process because it offered the first alternative to surgical sterilisation and promised a quick recovery.
Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.
According to a citizen's petition filed with the FDA, an inspector was given records of more than 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when majority interest in the company was acquired by Bayer. Both the agency and Bayer say Essure's benefits outweigh the risks.
Essure is sold in at least 23 countries, Bayer officials say, and some 750,000 devices are in use worldwide. Company officials declined to say how many American women use Essure, but said serious complications are relatively rare.
"There are no signals, nothing that would indicate a problem with Essure," said Dr Edio Zampaglione, vice president for medical affairs and women's affairs at Bayer. "The events being reported and seen are expected for this type of procedure."
But in interviews with more than a dozen patients, many said the risks were anything but expected.
Angie Firmalino, a 42-year-old mother of four in Tannersville, New York, said she experienced severe pain and non-stop bleeding for two years after the implant in 2009.
Doctors discovered that the coils had got lodged in her uterus and had broken apart. She has had several operations, including a hysterectomy, to remove the fragments.
In 2011, Firmalino created a Facebook page to warn friends and family about the device. The page now has nearly 17,000 members.
In 2000, Kim Hudak was a 28-year-old mother with a 7-year-old son when she volunteered to participate in an early trial of the device. But as soon as she received the implant, she said, she developed a sharp pain in her right hip that did not go away. Her menstrual periods became very painful, and she developed a slew of symptoms including fatigue, migraines and joint pain that kept her from working full time.
Hudak has filed a $1 million claim seeking reimbursement for injuries and lost wages.
Yet many women do well with Essure and recommend it." I had it done during my lunch hour, and I ran a half-marathon shortly afterward," said Cindy Dossett, 54, of Newburgh, Indiana.