Page 24 - ARUBA TODAY

A24 TECHNOLOGY
Monday 25 March 2019
FDA takes up decades-long debate over breast implant safety

By MATTHEW PERRONE of fears they might cause
AP Health Writer breast cancer, lupus and
WASHINGTON (AP) — U.S. other disorders. But when
health officials are taking studies seemed to rule out
another look at the safety most of the disease con-
of breast implants, the lat- cern, regulators returned
est review in a decades- the implants to the market
long debate. in 2006 with the require-
At a two-day meeting that ment that manufacturers
starts Monday, a panel of track recipients to see how
experts for the U.S. Food they fare long term.
and Drug Administration Implant makers Allergan
will hear from research- and Mentor — which is now
ers, plastic surgeons and part of Johnson &
implant makers, as well as Johnson — enrolled nearly
from women who believe 100,000 women in a 10-year
their ailments were caused study. But more than half of
by the implants. the women dropped out
The panel will consider next within three years, leaving
steps, but for now, the FDA insufficient data to draw
isn’t proposing any new re- firm safety conclusions.
strictions or warnings. The Last September, research-
agency’s longstanding po- ers at the University of Tex-
sition is that implants are This Dec. 11, 2006 file photo shows a silicone gel breast implant in Irving, Texas. as MD Anderson Cancer
essentially safe as long as Associated Press Center analyzed the com-
women understand they tic large cell lymphoma, pain. In the documents, the and an immune system dis- pany reports and found
can have complications, have involved a particular FDA reiterated its position order. She said her symp- that women with silicone
including scarring, pain, style of implants with a tex- that “there is not sufficient toms either resolved or im- implants seemed to have
swelling and implant rup- tured surface, designed evidence” linking them to proved after the implants greater rates of an immune
ture. But the FDA and other to reduce scar tissue and breast implants. The agen- were removed in 2015. system disorder called Sjo-
regulators around the world slippage. But the FDA said cy also sidestepped re- Breast augmentation is the gren syndrome, a connec-
have been grappling with it has also received reports quests from patients to add most popular form of cos- tive tissue disorder called
how to manage a recent- of the disease in smooth a boxed warning — the metic surgery in the U.S., scleroderma and the skin
ly confirmed link to a rare implants — which account agency’s most serious type with roughly 300,000 wom- cancer melanoma. But the
cancer and the thousands for most of the U.S. market — to breast implants and en undergoing the proce- authors acknowledged
of unconfirmed complaints — raising questions about to require manufacturers to dure each year. Another the limitations of the data,
of other health problems. whether the cancer is a risk give women a checklist of 100,000 women receive which often relied on in-
In documents released with both implant types. potential harms and com- implants for breast recon- complete, undiagnosed
before the meeting, FDA The disease is not breast plications before surgery. struction after cancer sur- patient reports. FDA regula-
regulators said it is “impos- cancer, but a form of can- “I’m a little discouraged,” gery. Most women choose tors said they “respectfully
sible” for them to deter- cer that attacks the im- said Jamee Cook, one of silicone gel-filled implants, disagree” with the conclu-
mine how frequently the mune system and usually more than 20 patients set to which are considered more sions.
cancer — a form of lym- forms in the scar tissue sur- speak at the meeting, after natural looking than saline Last week, the FDA sent
phoma — occurs because rounding implants. It grows reviewing the FDA materi- implants. warning letters to Men-
the U.S. does not track the slowly and can usually be als. “But I guess I’m hoping Implants first went on sale tor and a smaller implant
total number of implants successfully treated by sur- that what we have to say in the mid-1960s. But they maker, Sientra, for failing
on the market. Estimates gically removing the im- will prompt discussion on attracted little attention to enroll or retain enough
of the frequency of the dis- plants. those action points.” until the late 1980s, when patients in their long-term
ease range from 1 in 3,000 Thousands of women have A former paramedic, Cook a wave of lawsuits alleged studies. Allergan and the
women to 1 in 30,000. Most also blamed their implants said she had an array of serious harms and diseases other U.S. manufacturer
confirmed cases of the dis- for a host of ailments, in- health problems after get- linked to the devices. The of breast implants — Ideal
ease, known as breast im- cluding rheumatoid arthritis, ting implants in 1998, includ- FDA banned the silicone Implant — did not receive
plant-associated anaplas- chronic fatigue and muscle ing exhaustion, migraines gel type in 1992 because warnings.q

Florida man Googles self to find out which Florida Man he is

By MIKE SCHNEIDER to find out which headline That Impounded His Car, plained.” ing tales.
Associated Press pops up. Hits His Own Vehicle” and “Once, it seemed as For starters, it’s the na-
ORLANDO, Fla. (AP) — Then they must post the re- “Florida Man Tried to Pay for though all the weird peo- tion’s third largest state,
A new challenge mak- sult on social media. McDonald’s With Weed.” ple and stories came from with more than 20 million
ing waves on social me- The “Florida Man” concept The less common, but no California. residents, and a random
dia pokes fun at Florida’s crept into the nation’s con- less noteworthy, “Florida But over the past decade, sample of any population
reputation for producing sciousness with the @_Flori- Woman” subgenre has it shifted to Florida,” said that large is guaranteed
strange news stories involv- daMan Twitter account in produced headlines such Jim Clark, a lecturer in the to produce its share of the
ing guns, drugs, booze and 2013. as “A Florida woman was University of Central Flori- outrageous.
reptiles — or some combi- The account, with the tag- arrested and charged with da’s history department. Florida is also blessed with
nation of the four. line “Real-life stories of the aggravated assault without “Now, when I see a bizarre a liberal public records law
The challenge invites par- world’s worst superhero,” intent to kill after she report- story, I am surprised when it that allows these stories to
ticipants to run their birth- has been home to recent edly ‘farted loudly’ in a Dol- is not from Florida.” surface into plain view with
day and “Florida man” headlines such as “Florida lar Store and then pulled a A mixture of factors helps little resistance or concern
through a search engine Man Fire Bombs Garage knife on a man who com- Florida birth these astound- about taste.q