FDA allows sale of breast implantlinked to cancer, strengthenswarnings
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! Updated 5:53 PM ET, Thu May 2, 2019By Sandee LaMotte, CNN
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(CNN) — Despite an outcry from women to ban a particular type of breast implant
associated with a rare cancer, the sale of those implants will be allowed in the United
States, the Food and Drug Administration announced Thursday.
Women considering breast implants will soon receive more strongly worded
warnings about the dangers of the products before they decide to have the surgery,
and the agency will continue to study the issue.
At a two-day public advisory meeting in late
March, a number of women spoke out
about their health problems after receiving
breast implants.
One significant risk for women with
implants is the development of implant-
associated anaplastic large cell lymphoma
(BIA-ALCL), a type of non-Hodgkin
lymphoma, which is a cancer of the cells of
the immune system.
BIA-ALCL is predominantly associated with a textured type of implant, rather than
the smooth version. The illness is slow-growing and treatable when it's detected
early.
At least 457 women in the United States have been diagnosed with the cancer,
according to the FDA, and nine have died as a result. The cancer a`ects cells in the
immune system and can be found around the breast implant.
Acknowledging that international health agencies have been moving to ban the sale
of textured implants, the FDA says the market share in those countries can reach
80%, while market share in the United States is tiny in comparison.
"The type of macro-textured implants
targeted by some of our international
counterparts represents less than 5% of
breast implants sold here," the agency said
in a statement. "At this time, the FDA does
not believe that, on the basis of all available
data and information, the device meets the
banning standard set forth in the Federal
Food, Drug, and Cosmetic Act."
The lack of action is disappointing, said
Jamee Cook, co-founder of Breast Implant Victim Advocacy, who attended the
FDA's public meeting.
"Not banning the textured implants is very discouraging to us and to the patients
who have lymphoma," Cook said. "We're going to continue to push for that ban,
even though that's not a move they are willing to make yet."
About 10 million to 11 million women in the world have breast implants, according to
the American Society of Plastic Surgeons and the Plastic Surgeon Foundation.
The FDA raised the possibility of the illness in 2011, saying there was a small but
significant risk of the cancer after getting breast implants. It asked doctors whether
they'd noticed changes in their patients and urged women to check for symptoms
such as fluid buildup or a mass around their implants. Symptoms of the cancer also
include swelling and redness around the breast implants.
Since that report, the scientific community has learned more about the link between
breast implants and anaplastic large cell lymphoma.
Improving warningsBesides BIA-ALCL, the agency said it was concerned about the risk of implant
rupture and a condition called capsular contracture, in which the breasts become
hard and misshapen, causing chronic pain, and an increase in immune system
disorders.
"We have heard from patients concerned that their implants may be connected to
health conditions involving their immune system's response to these devices,
resulting in a variety of symptoms like chronic fatigue, cognitive issues, joint and
muscle pain," the FDA said.
While acknowledging that there was no
"definitive evidence demonstrating breast
implants cause these symptoms," the
agency said that the fact that many
immune issues disappear when the
implants are removed meant "women
considering a breast implant should be
aware of these risks."
Labeling changes such as box warnings
and a patient decision checklist could be
some of the ways the agency communicates some of the significant health concerns
associated with breast implants.
Those were key changes that Breast Implant Victim Advocacy wanted, Cook said.
"The FDA said they were just considering those actions," she said, "but based on our
conversations over the past few weeks, I really have high hopes they will pursue
those."
Cracking down on adverse-event reportingBreast implant manufacturers will also face a significant change in how adverse
events are reported, the FDA announced. In the past, manufacturers could provide a
summary of any patients problems or concerns, but that method did not capture
"unusual, unique or uncommon adverse events, which, in the case of breast
implants, included BIA-ALCL," the FDA said.
Moving forward, the manufacturers will be
required to file individual reports on adverse
events that will be made publicly available
in the coming weeks, the agency said.
Device Events founder Madris Tomes, who
developed a tool to search adverse events
in the FDA's database, said the action "was
a step in the right direction."
"It appeared that the summaries contained
a lot of data that should have been made
available before that meeting," she said, adding that adverse data should never be
withheld from the public.
The FDA also said it planned to increase its partnership with patients registry groups
such as PROFILE, which collects data on patients with BIA-ALCL diagnosis, and the
National Breast Implant Registry, which was established last year.
Though applauding the work of the
registries in its statement, the FDA said that
"more needs to be done to increase the
number of health care professionals
contributing to the registries and types of
information collected by the registries."
The agency pointed out that it was been
monitoring the risks of breast implants since 2011 and and considers the issue a
priority.
CNN's Jacqueline Howard and Kevin Flower contributed to this report.
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