FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

* Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
* Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
* There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
* Women should monitor their breast implants and contact their doctor if they notice any changes.
* Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.


The FDA published its literature review in a document posted on FDA's website site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses."

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

For more information:

ALCL and Breast Implants

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Breast Implant Consumer Information

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063717.htm

ALCL and Breast Implants Consumer Article

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm

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Fewer Teens Smoking, But More Teens Chewing Tobacco

/PRNewswire/ -- New data announced in today's Monitoring the Future study shows that while teen smoking rates are continuing their slow decline, an old threat has once again emerged - the use of smokeless tobacco. The study found that among 8th, 10th and 12th graders - all groups surveyed each year by the study - teen smoking rates among 8th and 12th graders continued to trend downward, while daily smoking amongst 10th graders crept upwards (5.9% in 2008 to 6.3% in 2009). Perhaps more concerning is the slight increase in daily smokeless tobacco use amongst 10th graders (now up to 1.9% in 2009 from 1.4 in 2008) and 12th graders (now 2.9 in 2009 up from 2.7 in 2008). Public health experts had predicted this increase in response to the tobacco industry's wide-ranging and aggressively marketed smokeless products now widely available.

The report, now in its 35th year, is the most respected source for data about youth smoking. In light of the findings in today's report, more needs to be done to reduce tobacco consumption writ large among the nation's youth. Also reported in today's announcement:

-- The perceived risk of using smokeless tobacco products has decreased
in all grades as has disapproval of smokeless products amongst 8th and
10th graders - a troubling trend indicating teens are not aware of the
harm smokeless products can cause and that they are a viable
alternative to cigarette smoking.
-- Teens prefer to date peers who do not smoke - 81.3% in 8th grade,
79.9% in 10th grade and 74.9% in 12th grade. This indicates that
social norms surrounding smoking continue to shift.



Legacy, the national public health foundation devoted to keeping young people from smoking and helping all smokers quit, has been committed to finding new ways to reach and engage with the teen audience, with the ultimate goal of reducing youth smoking prevalence. This is especially important as the tobacco industry continues to successfully market its products and addict new smokers.

The public health community, doctors and parents must work together to foster a continued rate of decline. The Master Settlement Agreement reached in 1998 between attorneys general from 46 states, five US territories and the tobacco industry provided our country with a unique opportunity - and with focused funding -- to address youth smoking and help smokers who want to quit.

About eighty percent of all smokers have their first cigarette before age 18(1), and every day 1,500 youth become daily smokers(2). These daily smokers will continue down a path of tobacco-related diseases and will incur higher healthcare costs than nonsmoking Americans. Funding youth smoking-prevention efforts could prevent these ill effects.

On heels of today's study release, the "Broken Promise to Our Children: The 1998 State Tobacco Settlement 11 Years Later" report released last week by the Campaign for Tobacco Free Kids and other leading public health groups, found that despite two sources of revenue -- funding provided through the Master Settlement Agreement and funding from taxes placed on tobacco -- states are spending just 2.3 percent of revenue from tobacco settlement and tobacco taxes on tobacco prevention and cessation programs.

The Monitoring the Future study has concluded that mass media campaigns can reduce smoking, especially when combined with other tobacco control strategies. However, youth smoking prevention campaigns sponsored by the tobacco industry have been ineffective and may actually have increased youth smoking.

The foundation's truth(R) youth smoking prevention campaign is a national effort that delivers facts and messages to teens about tobacco, but avoids giving directive statements telling youths not to smoke. Research has indicated that in the first four years of the campaign, 18 percent of the overall decline in youth smoking was directly attributable to truth(R). As the only organization directing a national media campaign for youth smoking prevention - other than the tobacco industry - it is critical that funding continues to grow for efforts like the truth(R) campaign and state-specific smoking prevention campaigns.

Legacy(SM) is dedicated to building a world where young people reject tobacco and anyone can quit. Located in Washington, D.C., the national public health organization helps Americans live longer, healthier lives. Legacy develops programs that address the health effects of tobacco use, especially among vulnerable populations disproportionately affected by the toll of tobacco, through grants, technical assistance and training, partnerships, youth activism, and counter-marketing and grassroots marketing campaigns. The foundation's programs include truth(R), a national youth smoking prevention campaign that has been cited as having contributed to significant declines in youth smoking; EX(R), an innovative public health program designed to speak to smokers in their own language and change the way they approach quitting; and research initiatives exploring the causes, consequences and approaches to reducing tobacco use. The American Legacy Foundation was created as a result of the November 1998 Master Settlement Agreement (MSA) reached between attorneys general from 46 states, five U.S. territories and the tobacco industry. Visit www.legacyforhealth.org

(1) Mowery PD, Brick PD, Farrelly MC. Legacy First Look Report 3. Pathways to Established Smoking: Results from the 1999 National Youth Tobacco Survey. Washington DC: American Legacy Foundation. October 2000.

(2) MMWR. 1998. Decline Selected Cigarette Smoking Initiation and Quitting Behaviors Among High School Students. 47(19):386-389.

California Office of Environmental Health Hazard Assessment Review Verifies Safety of Synthetic Turf

/PRNewswire/ -- Representing the latest convincing data on the safety of synthetic turf, the California Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, released a report last week dated July 2009 which indicated there is a negligible human health risk from inhaling the air above synthetic turf. The OEHHA summary also stated "it is unlikely that the new generation of artificial turf is itself a source of MRSA."

OEHHA searched the available literature related to the safety of new generation artificial turf fields, those which contained crumb rubber infill. They analyzed whether these fields emitted levels of chemicals or particulates into the air that are a health risk when inhaled, and also any potential risk factors for MRSA infection. Based on the data from two 2009 New York studies and a 2006 report of indoor fields, they found that "Both reports concluded that these fields did not constitute a serious public health concern, since cancer or non-cancer health effects were unlikely to result from these low-level exposures." Other key findings included:

-- Analyzing the chemicals detected above the fields in New York, OEHHA
noted that "many of these occurred at similar concentrations in the
air sampled upwind of the fields" - which suggests that the source of
these chemicals was not from the turf fields.


-- Cancer risks are negligible, lower than many common human activities.
OEHHA created a test scenario to determine the exposure and health
risks of an athlete playing on an artificial turf field from age five
until age 55 for nearly 100 chemicals. The results showed an exposure
to five chemicals with a lifetime cancer risk above one in one
million, which is considered a negligible risk. As OEHHA explains
"these estimated risks are low compared to many common human
activities." To give context, their website states that the cancer
risk of breathing California air (in 2000) due to diesel particles was
540 in one million.


-- Synthetic turf is not a source of MRSA. OEHHA stated that "It seems
unlikely that the new generation of artificial turf is itself a source
of MRSA, since MRSA has not been detected in any artificial turf
field." That conclusion is consistent with the findings of the Penn
State January 2009 study conducted on the lifespan of staph on grass
and synthetic turf, which was sponsored by the STC and the
Pennsylvania Turfgrass Council.

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