UPDATED July 24, 2019, with new FDA statement.
The FDA said today that it asked Allergan (NYSE: AGN)
to recall its Biocell breast implants after concluding that they are
six times as likely as other textured breast implants to cause an
uncommon form of lymphoma.
The federal safety watchdog said that nearly 84% of the 573 cases of
breast implant-associated anaplastic large cell lymphoma reported
worldwide – including 33 deaths – involved patients implanted with the
Allergan implants; of the 13 deaths in which the manufacturer was known,
12 involved Allergan (the implant maker is unknown in the other 20
deaths, the FDA said).
“Based on the currently available information, including the newly
submitted data, our analysis demonstrates that the risk of BIA-ALCL with
Allergan Biocell textured implants is approximately six times the risk
of BIA-ALCL with textured implants from other manufacturers marketing in
the U.S.,” the agency said, noting that “continued distribution of
Allergan’s Biocell textured breast products implants would likely cause
serious, adverse health consequences and potentially death from
BIA-ALCL.”
Although the FDA this year declined to impose a ban on the implants, despite a surge in adverse event reports, regulators in several foreign jurisdictions are considering or have already enacted bans on textured implants. In March the bureau warned breast implant manufacturers Sientra (NSDQ:SIEN) and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over failures to conduct appropriate post-approval studies of the devices.
Allergan, which pulled Biocell from the European market last December, said it’s doing the same worldwide as a precaution based on the newly reported BIA-ALCL risk.
“Biocell saline-filled and silicone-filled textured breast implants
and tissue expanders will no longer be distributed or sold in any market
where they are currently available,” the company said. “Effective
immediately, healthcare providers should no longer implant new Biocell
textured breast implants and tissue expanders and unused products should
be returned to Allergan.”
The company advised Biocell patients to speak with their plastic
surgeon about the risks and benefits of their implant type should they
have any concerns. Explantation is not recommended in asymptomatic
patients, Allergan said, noting that its Natrelle and Microcell smooth breast implants are not affected by the recall.
https://www.prnewswire.com/news-releases/allergan-
https://www.cnn.com/2019/05/02/health/fda-breast-implant-dangers/index.html
https://www.youtube.com/watch?v=eadUaggcYd0
https://www.today.com/health/allergan-recalls-textured-breast-implants-linked-bia-alcl-cancer-t159463
https://www.journalpioneer.com/news/world/fda-
https://www.thestar.com/news/investigations/2019/07/24
https://www.youtube.com/watch?time_continue=1&v=NZ19yYs_Na0
https://www.youtube.com/watch?time_continue=78&v=j5JGdnAZW2s
https://www.wagners.co/biocell-textured-breast-implants/
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