Experts question safety of Essure device linked to pain

AP News
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Posted: Sep 24, 2015 7:48 PM
Experts question safety of Essure device linked to pain

WASHINGTON (AP) — A 13-year-old birth control implant came under new scrutiny Thursday as federal health experts discussed a host of problems reported by women implanted with the metallic device, including chronic pain, bleeding and fatigue.

The Essure implant from German manufacturer Bayer is frequently pitched to women as the only non-surgical option for permanent birth control.

But since 2013, the Food and Drug Administration has received thousands of complaints about the device from women and doctors. The agency convened a meeting Thursday to have its outside experts review Essure's safety and effectiveness. The panel's recommendations are not binding.

While Essure's label warns about pelvic pain, bleeding and allergic reactions shortly after the implant procedure, many women say these problems persist and can be so severe they require invasive surgery to remove the device.

Panelists said more data is needed on allergic reactions to the device and how to spot signals that women are likely to develop long-term problems. Additionally, the group said doctors need more training on how to properly place and remove the devices, which can sometimes move, shatter or puncture parts of the uterus and bowels.

The audience at Thursday's meeting included dozens of women pushing for the withdrawal of Essure who frequently applauded critical comments by the panelists.

In one exchange, panelists grilled Bayer representatives about their studies of Essure, which is made of a nickel-titanium alloy. Because nickel allergies are common, panelists asked why Bayer didn't do more research on reactions to the metal.

"How can we not have data on nickel allergy when you have a device that is 55 percent nickel and 20 percent of women are known to be nickel allergic?" asked Dr. Peter Schalock of Harvard Medical School. "Why is there no data on that in your package?"

Representatives for Bayer said that skin tests for nickel allergies do not accurately predict whether a patient will have an allergic reaction to a nickel implant. The company added that many medical devices contain nickel, including heart valves and stents.

Earlier in the day, more than 20 women from throughout the U.S. described debilitating symptoms which they attributed to Essure.

Elena Mendez received her implant in February 2008 at the recommendation of her doctor. An emergency room nurse in New York, Mendez said she liked the idea that it could be implanted via a quick, in-office procedure.

But soon afterward Mendez began experiencing severe, constant pain, especially during sex.

"Pain became my norm every day," Mendez said. "This negatively impacted my marriage and I could not be the mother my children deserved."

There is no timeline for action by the FDA, which is not required to follow the advice of its outside experts.

Essure consists of coils inserted into the fallopian tubes, where they are intended to spur scar tissue that eventually blocks sperm. Bayer sells the device as an alternative to traditional procedures used to "tie the tubes." The company estimates 750,000 women have received the implant since 2002. Bayer acquired the device through its 2013 acquisition of American device firm Conceptus Inc. for about $1 billion.

Essure's warning labeling lists a number of potential risks, including that the device can slip out of position or puncture the uterus, requiring surgery to remove. The label notes that the device's nickel can result in allergic reactions, such as itching and hives

But thousands of women have attributed more severe problems to the implant, including chronic pain, headaches, mood disorders, hair loss and irregular bleeding. Many of those complaints have been shared through social media, including a Facebook page called Essure Problems, which has over 20,000 members.

The dilemma confronting the FDA is not a new one.

The agency has repeatedly approved medical devices based on short-term studies suggesting they are safe and reliable. But real-world experience with devices like hip replacements, vaginal mesh and pacemakers often doesn't match that seen in controlled studies.

In the case of Essure, the original company studies suggested the implant prevented pregnancy in 97 percent of cases with few side effects. But the studies only tracked 85 percent of women out to a year and only 25 percent of women were followed for two years. Researchers from Yale University said this drop-out rate "limited the evaluation of adverse events and device safety," in an op-ed in this week's New England Journal of Medicine.

"I think we could do better for women by getting better information," said Dr. Aileen Gariepy of Yale School of Medicine, in an interview with The Associated Press.