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By RONI CARYN RABIN The New York Times (FiDA highlight added)
MAY 3, 2015
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 sterilization 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, was published on Friday after an unusual eight-year delay. Several patients have sued 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 F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization 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 citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company. Both the agency and Bayer say Essure’s benefits outweigh the risks.
Essure is sold in at least 23 countries, Bayer officials say, and about 750,000 devices are in use worldwide. Company officials declined to say how many American women use Essure, but said serious complications were relatively rare.
“There are no signals, nothing that would indicate a problem with Essure,” said Dr. Edio Zampaglione, vice president for United States 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, N.Y., said she had experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009.
Eventually doctors discovered that the coils had somehow lodged in her uterus and had broken apart. She has had several operations, including a hysterectomy, to remove the fragments.
In 2011, Mrs. Firmalino created a Facebook page to warn friends and family about the device. The page now has nearly 17,000 members.
“If I had any idea of the possible consequences of Essure, I would never have chosen it,” said Mrs. Firmalino, who still takes ibuprofen daily to manage her pain.
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 often kept her from working full time.
“It felt like I had a really severe case of the flu, and those were the good days,” said Ms. Hudak, now 43, who works in sales in Cleveland. “I had years and years of doctors telling me I was crazy.”
Ms. Hudak has filed a $1 million claim against Bayer 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, Ind.
She required another procedure to curb menstrual bleeding after getting the implant, but over all, she said, “it’s a pretty easy process.”
Essure was the first device to offer women an alternative to tubal ligation (commonly known as having one’s “tubes tied”) and, as such, was considered a game changer, experts said.
The small coils are placed in the fallopian tubes vaginally, without a surgical incision and with minimal anesthesia.
Once inserted, the coils — made of a nickel titanium alloy and a polyesterlike fiber called polyethylene terephthalate, or PET — trigger an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing sperm from reaching an ovum. The scarring process can take three months, and women must use other contraceptives until testing confirms the tubes are blocked.
But pain and other serious side effects emerged early in clinical trials required for approval.
In a safety trial that enrolled 269 women ages 23 to 45, the device was successfully inserted into 200 patients. In nine of them, a coil perforated the fallopian tube, was expelled or lodged elsewhere in the body, according to a 2003 report in the journal Human Reproduction.
Trial participants were asked to keep diaries, and nearly one in 10 participants recorded painful intercourse, while one in eight had painful menstrual periods during the first three months.
In a subsequent trial of 518 women, only 449 were able to rely on the device. On 21 occasions, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.
Participants again reported back pain, abdominal pain and pain with intercourse.
At the time, F.D.A. officials were concerned that the trials had followed women only for a year or two, while the implant was meant to last a lifetime. The agency approved Essure in 2002 on condition that the investigators continue to monitor the women who participated in the trials for four more years.
The F.D.A. said only 171 women in the smaller trial were followed for five years. A heavily redacted report, posted on the F.D.A. website, shows that five women had hysterectomies and that at least one became pregnant.
Participants reported 270 adverse events, including dozens involving pain and heavy menstrual periods. The investigators determined that only 17 of these were caused by Essure and attributed the rest to other factors. They concluded that pain and bleeding were therefore rare among users.
Although the monitoring period ended in 2007, long-term data on women in the larger trial was published only last week in the Journal of Minimally Invasive Gynecology.
Of the original 518 participants, whose average age was 31, only 366 — about 70 percent — were followed for the full five years.
Fifteen women had hysterectomies. The investigators concluded that only two of these major operations were “possibly” related to Essure.
Thirty-eight percent experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, one in 15 had recurrent painful periods, nearly one in 25 had recurring pain with intercourse. Investigators said just one had persistent pain, however.
Because there is no other device like Essure on the market, and because Bayer will not say how many American women have it, experts find it difficult to judge whether the risks are disproportionate. Manufacturers are not required to include control groups in clinical trials, as is standard in drug trials, so there is no comparison group.
F.D.A. officials said they were concerned about the coils moving outside the fallopian tubes, but did not believe the device was flawed.
“The agency believes the benefits outweigh the risks in appropriately selected patients who are adequately informed,” said Dr. William Maisel, deputy director for science and chief scientist in the F.D.A.’s Center for Devices and Radiological Health.
Dr. Zampaglione said women who underwent surgical sterilization were also more likely than other women to undergo hysterectomy. A 1998 study of women undergoing surgical sterilization in the 1970s and ’80s also found high rates of subsequent hysterectomies, he said.
The slowly accumulating data and patient reports, however, have made other experts uneasy.
The National Center for Health Research, a nonprofit group, has begun analyzing adverse event reports related to Essure, looking for patterns of complications.
“The fact that 16,000 women with children and a lot of things to do are willing to take the time to talk about this is very, very unusual,” said Diana Zuckerman, president of the group, referring to Mrs. Firmalino’s Facebook page. “I can’t think of another device like this.”
Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, has calculated that nearly one in 10 women with Essure would get pregnant over a 10-year period, a much higher rate than that among women who undergo tubal ligation.
She finds it troubling that the long-term study published last week did not include data on 30 percent of the trial participants.
In clinical trials, she said, “the most common reason patients are lost like this is because they had a problem.”
Physicians familiar with Essure are now deeply divided. Many use it regularly and say they have had tremendous success.
“It’s the best thing out there,” said Dr. Jeffrey Bittner, a gynecologist in Ottumwa, Iowa. “It’s easy, it’s safe, it’s effective — it’s hard to beat. A doctor who doesn’t tell patients that is not being honest.”
Others have become disillusioned.
“When Essure came out, I was very enamored by it and did a lot of Essures all the time, until I started seeing patients come back with problems and referred to me with complications,” said Dr. Mitchell D. Creinin, professor of obstetrics and gynecology at U.C. Davis Health System in Sacramento.
“It’s a great technology. I’m just not sure it’s ready for prime time.”