Allergan Recalls Breast Implants After FDA Cites Lymphoma Link -- Update
July 24 2019 - 4:08PM
Dow Jones News
By Peter Loftus
Allergan PLC recalled certain textured breast implants from the
market after U.S. health regulators said there was an increase in
cases of a rare type of cancer and deaths among women receiving the
implants.
The U.S. Food and Drug Administration said Wednesday it asked
Allergan to recall the implants because their continued sale "would
likely cause serious, adverse health consequences and potentially
death" from a cancer known as breast-implant-associated anaplastic
large cell lymphoma, which develops in the body's immune
system.
The FDA noted that the type of textured implants in question are
a small portion of implants sold in the U.S., but that the risk
associated with Allergan's implants was about six times the risk
with similar types of implants from other manufacturers, including
Johnson & Johnson. Hundreds of thousands of women have received
the recalled Allergan implants, an FDA official said.
"While the overall incidence appears to be relatively low, once
the evidence indicated the Allergan product was linked to patient
harm including deaths, the FDA took action," Amy Abernethy, the
FDA's principal deputy commissioner, said on a conference call with
reporters. "We know that today's news will be alarming to patients
with breast implants."
The move came two months after the FDA said it didn't plan to
ban any breast implants over various safety issues it had examined,
saying there wasn't sufficient evidence. Instead, the FDA at that
time tightened the requirements for implant manufacturers to report
health problems in patients receiving them.
The FDA for years has been monitoring the safety of implants
used for breast augmentation or reconstruction, and in 2011 first
warned of the potential risk of anaplastic large cell lymphoma from
implants.
Dublin-based Allergan said Wednesday it is globally recalling
its Biocell textured breast implants, which have a rougher surface
designed to adhere to surrounding tissue and make them less likely
to become repositioned than smooth breast implants. The recall also
includes products known as tissue expanders that are used in
breast-implant surgery. Allergan said surgeons should no longer use
the recalled implants or expanders.
The FDA said it has now received reports of 573 cases of the
implant-associated lymphoma and 33 deaths of such patients. The FDA
attributed some 84% of the 573 cases to Allergan implants. Among
the deaths, 12 of the 13 patients for which the implant's
manufacturer was known were patients with Allergan textured
implants at the time of diagnosis, the FDA said. The manufacturer
or texture is unknown for the remaining 20 reported deaths, the FDA
said.
The FDA's new tally of lymphoma cases and deaths is up
significantly from an FDA update in February, when the agency said
there were 457 cases including nine deaths.
The FDA said the recall will ensure that unused implants are
removed from suppliers' and doctors' offices. The FDA isn't
recommending removal of implants in patients without symptoms
because the risk of developing lymphoma is low, and there are
safety risks associated with removal.
Patients with confirmed cases of lymphoma should undergo
implant-removal surgery and removal of the surrounding scar tissue,
the FDA said. Patients with the recalled implants should talk to
their doctor if they experience symptoms, which include persistent
swelling or pain near the implant.
FDA officials said they haven't ruled out the possibility that
smooth implants could increase the risk of lymphoma because some of
the reported lymphoma cases include women with smooth implants. But
in some of those cases, the women previously had textured implants,
so it was less clear that the smooth implants were increasing risk,
said Jeffrey Shuren, director of the FDA's Center for Devices and
Radiological Health.
Health regulators in some countries including France have banned
or restricted sales of textured implants. Allergan suspended sales
of its textured breast implants in Europe and withdrew the
remaining textured breast implants then on the market in Europe in
the fourth quarter of 2018. Textured implants are used more
commonly in Europe than in the U.S.
Allergan posted a list of the recalled breast implants and
tissue expanders online.
More than a dozen lawsuits have been filed against Allergan in
the U.S. and Canadian courts alleging the company's textured breast
implants caused women to develop lymphoma. The suits also allege
Allergan failed to properly warn against this risk and failed to
promptly and properly report the results of certain studies
relating to these products, Allergan said in a securities filing in
May.
An Allergan spokeswoman said the company declines comment on
pending legal matters.
Allergan's total breast implant sales were $263 million in
2018.
Allergan, which also makes the cosmetic product Botox, has
agreed to be acquired by AbbVie Inc. for about $63 billion.
Completion of the deal is pending.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
July 24, 2019 15:53 ET (19:53 GMT)
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