Page 28 - aruba-today-20180721

A28 SCIENCE
Saturday 21 July 2018
Bayer to stop sales of birth control device tied to injuries

By MATTHEW PERRONE and er supplied to doctors and
LINDSEY TANNER patients lists potential prob-
WASHINGTON (AP) — The lems and says the devices
maker of a permanent are meant to be perma-
contraceptive implant nent. It also says removal
subject to thousands of in- may require complicated
jury reports and repeated surgery, including a hyster-
safety restrictions by regu- ectomy, that might not be
lators said Friday that it will covered by insurance.
stop selling the device in Gottlieb noted that device
the U.S., the only country removal "has its own risks."
where it remains available. Diana Zuckerman, presi-
Bayer said the safety of dent of the nonprofit Na-
its Essure implant has not tional Center for Health
changed, but it will stop Research, said Essure is
selling the device at the among medical devices
end of the year due to approved without "clear
weak sales. evidence of safety or ef-
The German company had fectiveness."
billed the device as the "As a result, when thou-
only non-surgery steriliza- sands of women reported
tion method for women. As serious complications from
complaints mounted and Essure, there was no unbi-
demand slipped, it stopped ased long-term research
Essure sales in Canada, Eu- to refute or confirm those
rope, South America, South reports," Zuckerman said. "If
Africa and the United King- patients had been listened
dom. to when the first clinical tri-
The U.S. Food and Drug als were conducted on Es-
Administration has placed sure, better research would
multiple restrictions on the have been conducted to
device following patient determine exactly how
reports of pain, bleeding, safe and effective Essure
allergic reactions and cas- This image provided by Bayer Healthcare Pharmaceuticals shows the birth control implant Essure. is."
es where the implant punc- Associated Press Dr. Kristyn Brandi, a Los An-
tured the uterus or shifted geles family planning spe-
out of place. and promoted it as a quick expected enrollment num- causing problems, such as cialist, called Bayer's move
In May, the FDA said doc- and easy permanent solu- bers" for new patients. The persistent pain, should con- disappointing. She says
tors must show women a tion to unplanned preg- study was designed to fol- sult with their doctors, Got- most of her Essure patients
checklist of the device's nancies. Essure consists of low patients for three years tlieb added. have been satisfied.
risks before implanting it. two thin-as-spaghetti nick- to better assess complica- Essure's original label "I would hope Bayer would
More than 16,000 U.S. wom- el-titanium coils inserted tions. warned that the device's use this opportunity to think
en are suing Bayer over Es- into the fallopian tubes, More than 750,000 women nickel can result in allergic about future research and
sure. where they spur the growth worldwide have received reactions. Its current label- product development,"
One of them, Amanda Rus- of scar tissue that blocks Essure. Demand has de- ing lists hives, rash, swelling Brandi said. "Being able to
misell, of Charlotte, North sperm from fertilizing a clined in recent years and and itching as possible re- offer women contracep-
Carolina, said she's "im- woman's eggs. plunged 70 percent after actions. tion that's permanent with-
mensely thrilled" by Bayer's Because of the reported the 2016 boxed warning, But many women have out surgery is a really great
action. Rusmisell said she complaints, the FDA add- the FDA said. attributed other problems option."
got the device in 2008 and ed its most serious warning Gottlieb said the FDA will to the implant, including Bayer spokeswoman
developed severe pain to the device in 2016 and continue to monitor ad- mood disorders, weight Courtney Mallon said the
and bleeding. She took ordered the company to verse events reported to gain, hair loss and head- company had no plans to
part in patient-organized conduct a 2,000-patient its database after Essure is aches. Those problems are re-design the device.
rallies accusing Bayer for study. removed from the market. listed in the current FDA la- Kate Nicholson, of Dallas,
not disclosing potential risks FDA Commissioner Scott "I also want to reassure beling for the device, with got an Essure implant last
and said, choking back Gottlieb said Friday the women who've been using the qualifier: "It is unknown year after she and her hus-
tears, "Our very grassroots agency would work with Essure successfully to pre- if these symptoms are re- band decided not to have
effort has worked." Bayer to continue the vent pregnancy that they lated to Essure or other children. She said she sym-
Bayer received FDA ap- study, but noted "Bayer can continue to do so," he causes." pathizes with women who
proval to sell Essure in 2002 will not be able to meet its said. Those who think it's Informational material Bay- have had problems but
said ending Essure sales is
the wrong move.
"Pulling it from the market
is yet another way to limit
our choices about our own
bodies," Nicholson said. "I
personally always had hor-
rible experiences with dif-
ferent versions of 'the pill,'
but it's still on the market
and many women swear
by it."q