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A28 SCIENCE
Thursday 24 OcTOber 2019

This Dec. 11, 2006 file photo shows a silicone gel breast implant
in Irving, Texas. On Wednesday, Oct. 23, 2019, the U.S. Food
and Drug Administration said that breast implant manufacturers
should add a boxed warning — the most serious type — to
information used to market and prepare patients for implants.
Associated Press
FDA wants stronger

warning on breast This image provided by Swedish Match in 2019 shows the company's "General Snus" pouched
smokeless tobacco product.
implants about risks U.S. endorses tobacco pouches Associated Press

By MATTHEW PERRONE sidered lifelong devices.
AP Health Writer About 1 in 5 women who as less risky than cigarettes
WASHINGTON (AP) — get implants for cosmet-
U.S. health officials want ic reasons need to have By MATTHEW PERRONE lar chewing tobacco, the smokers who are used to
women getting breast im- them removed within 8 to AP Health Writer liquid from snus is gener- inhaling their nicotine, said
plants to receive stronger 10 years, according to the WASHINGTON (AP) — For ally swallowed, rather than Vaughan Rees, director of
warnings and more details FDA. The agency will take the first time, U.S. health spit out. Chewing tobacco Harvard University's Center
about the possible risks and public comment on the regulators have judged a is fermented; snus goes for Global Tobacco Con-
complications. proposed guidelines be- type of smokeless tobac- through a steamed pas- trol.
The Food and Drug Admin- fore adopting them. co to be less harmful than teurization process. The U.S. smoking rate has
istration said Wednesday The new proposal is the cigarettes, a decision that FDA acting commissioner fallen to an all-time low of
that manufacturers should FDA's latest attempt to could open the door to Ned Sharpless said the 14% of adults, or roughly
add a warning highlighted manage safety issues with other less risky options for agency based its decision 34 million Americans. But
by a box — the most serious the devices primarily used smokers. The milestone an- on long-term, population- smoking remains the lead-
type — to the information for breast augmentation, nouncement on Tuesday level data showing lower ing cause of preventable
given to women consider- the most frequently per- makes Swedish Match to- levels of lung cancer, em- disease and death in the
ing implants. formed cosmetic surgi- bacco pouches the first physema and other smok- U.S., responsible for some
The agency is also recom- cal procedure in the U.S. so-called reduced-risk to- ing-related disease with 480,000 deaths annually.
mending patients com- Roughly 400,000 women bacco product ever sanc- the use of snus. The FDA's decision has
plete a checklist to make get implants each year; tioned by the Food and Sharpless added that the been closely watched by
sure they understand all the 100,000 after cancer sur- Drug Administration. agency will closely monitor both public health experts
possible side effects of the gery. In recent years, the FDA regulators stressed Swedish Match's marketing and tobacco companies.
implants, such as scarring, FDA and regulators else- that their decision does efforts to ensure they target Public health experts have
pain, rupture and even a where have grappled with not mean the pouches are adult tobacco users. long hoped that alterna-
rare form of cancer. a link between a rare can- safe, just less harmful, and "Anyone who does not cur- tives like the pouches could
"We have heard from many cer and a type of textured that all tobacco products rently use tobacco prod- benefit Americans who are
women that they are not implant. In July, the FDA pose risks. The pouches will ucts, especially youth, unable or unwilling to quit
fully informed of the risks called on manufacturer still bear mandatory gov- should refrain from doing cigarettes and other tradi-
when considering breast Allergan to pull its Biocell ernment warnings that they so," he said in a statement. tional tobacco products.
implants," the agency said implant after it was tied to can cause mouth cancer, Stockholm-based Swedish Tobacco companies are
in a statement detailing the heightened risk of a form of gum disease and tooth loss. Match sells its snus under looking for new products to
recommendations. lymphoma. The company But the company will be the brand name, General, sell as they face declining
The agency also wants issued a worldwide recall able to advertise its to- in mint, wintergreen and cigarette demand due to
companies to explain that for the implants, which had bacco pouches as posing other flavors. They com- tax increases, health con-
breast implants often re- already been restricted or a lower risk of lung cancer, pete against pouches from cerns, smoking bans and
quire repeat surgeries and removed from numerous bronchitis, heart disease rivals Altria and R.J. Reyn- social stigma.
they should not be con- countries.q and other diseases than olds. But pouches account The FDA itself also has
cigarettes. The pouches of for just 5% of the $9.1 billion- much at stake in the review
ground tobacco, called dollar U.S. market for chew of snus and similar tobacco
snus — Swedish for snuff and other smokeless to- alternatives.
and pronounced "snoose" bacco products, accord- Congress gave the FDA
— have been popular in ing to Euromonitor market the power to regulate key
Scandinavian countries for research firm. aspects of the tobacco
decades but are a tiny part And public health experts industry in 2009, including
of the U.S. tobacco market. questioned whether U.S. designating new tobacco
Users stick the teabag-like smokers would be willing to products as "modified risk,"
pouches between their switch to the niche prod- compared with traditional
cheek and gum to ab- uct. "Snus products have a cigarettes, chew and other
sorb nicotine. Unlike regu- bit of a challenge" among products.q