Alicja Ugnire blog

FDA Says Breast Implants Linked to Rare Cancer

WEDNESDAY, Jan. 26 (HealthDay News) -- The U.S. Food and Drug Administration said on Wednesday that breast implants may be linked to a heightened risk for a rare cancer, as evidenced in a small but growing number of cases that have been reported in recent years.

The agency now says that both silicon and saline implants may be linked to anaplastic large cell lymphoma (ALCL), which could develop within the scar tissue left by the implant procedure.

But the absolute risk to any one woman is likely to be very low, experts stressed.

"Lymphoma is a cancer involving cells of the immune system and ALCL is a very rare type of lymphoma," Dr. William Maisel, chief scientist and deputy director for science at the FDA's Center for Devices and Radiological Health, said during an early afternoon press conference Wednesday.

"The FDA believes that women with breast implants may have a small, but increased, risk of developing ALCL," he said.Only about one of every 500,000 American women each year are diagnosed with ALCL, Maisel said, and "ALCL in the breast is even more rare, occurring in three of every 100 million in the United States."

He added that "ALCL in the breast is not the same as breast cancer."

Of the 5 million to 10 million women around the world who have implants, the FDA says it now knows of roughly 60 cases of ALCL. That number has been tough to verify, the agency said, since some cases may have been duplicated in separate reports.

The agency is asking doctors to report any cases of ALCL, and for makers of implants to update their labeling and other information to disclose the potential hike in risk to both doctors and patients.

The agency's decision is also based of studies published from 1997 to 2010 that identified 34 cases of ALCL among women with either silicon or saline implants around the world, Maisel said.

Among these cases, 24 were related to silicon implants, seven to saline implants and the type of implant in the remaining three cases are not known, according to the FDA. In addition, 19 of the implants were inserted for cosmetic reasons and 11 were used in reconstructive procedures. The reasons for the other four procedures are not known, the agency said.

The majority of cases the agency is aware of came to light when women went to a doctor complaining of symptoms such as pain, lumps, swelling or anomalies in their breasts. These symptoms were the result of"fluid, hardening of breast area around the implant, or masses surrounding the breast implant," the agency said. ALCL was found by testing the fluid and area around the implant.

Symptoms of ALCL can develop from one to 23 years after a women gets her implants, according to the FDA.

"Women with breast implants who are not showing any symptoms or problems require only routine follow-up," Maisel said. "Physicians should consider the possibility of ALCL if the patient has late-onset and persistent fluid around the implant," he added.

"Women should monitor their implants and report any noticeable changes to their doctors, particularly those that occur after the breast implants are fully healed," Maisel said.

ALCL is usually treated with chemotherapy and radiation, and sometimes surgery, Maisel noted.

"I suspect this has caught the vast majority of plastic surgeons off-guard, as we have not heard anything remotely related to a potential warning before today," said Dr. Jeffrey C. Salomon, an assistant clinical professor of plastic surgery at Yale University School of Medicine.

This rare lymphoma develops in the naturally occurring capsule of tissue that normally forms around the implant, he said. "It is somewhat distressing to surgeons and patients alike but, the overall risk is exceedingly low," Salomon added.

Maisel added that American Society of Plastic Surgeons (ASPS) is working with the FDA to set up a registry of cases so the agency can get a better idea of the relationship between implants and ALCL.

However, the president of the society was wary of the public overreacting to the risk.

"ASPS shares the FDA's commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients," Dr. Phillip Haeck said in a statement. "We've been down this path before. For nearly 20 years, American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn't happen again."

Haeck is referring to the belief that silicon implants were associated with breast hardening, breast pain, breast implant rupture, and the need for additional surgery and a possible risk of cancer, which caused the FDA to ban them for 14 years.

After further review, the FDA allowedsilicon implants to return to the market in 2006.

Commenting on the FDA's announcement, Dr. Jasmine Zain, director of the Rita J. and Stanley H. Kaplan Stem Cell/Bone Marrow Transplant Center and an assistant professor in the department of medicine at the NYU Langone Medical Center in New York City, said that she was "aware of the link between breast implants and ALCL."

"About five years ago, my colleagues and I discovered that there was a link between lymphoma and breast implants in several patients we treated. Over the years, other doctors have noted the link between rare lymphoma and breast implants. The occurrence is very rare, but women have to be very careful," Zain said."Women should be aware of the risk when deciding whether or not to get breast implants. Women thinking about getting breast implants and women with breast implants should talk to their doctors and be informed of the risk."

More information

For more information on breast implants, visit theU.S. Food and Drug Administration.

Adobe launches Acrobat X Pro, new cloud services

Adobe on Monday launched its much-anticipatedprogram, along with a pair of two new cloud-based subscription services to enable the creation and sharing of PDF documents.

offers users new features such as the Quick Tools customizable toolbar and the Action Wizard, which allows the automation of multi-step tasks that can then be applied to a single document or batches of files.

Acrobat X Pro also offers new customization options for PDF portfolios, allowing professional users to create and share custom layouts and themes for consistent branding. The program's printing options and preview tool have also been upgraded, and the company promises Acrobat will have tight integration with its services at

The cloud-based services areand . SendNow is a document exchange service available that lets users send, download, track, and manage documents; the service helps users avoid e-mail gateway issues, FTP servers, or the need to print documents and send them through the postal service.

CreatePDF enables online PDF creation from computers that aren't running Acrobat, using the browser to convert files created by Microsoft Office, Adobe InDesign, Photoshop, Illustrator and other supported programs. The services each cost $10 for a monthly subscription, although free trials are available.

R. Kelly sending out 'Love Letter" on December 14

NEW YORK (Billboard) – With soulful new single, "When a Woman Loves," already making an impact at radio, R. Kelly will release its accompanying album, "Love Letter," just in time for the holidays.

The singer's latest R&B opus arrives December 14 on Jive Records, with a second single and a Christmas remix coming this month.

Kelly's 11th studio album will include "When a Woman Loves," which the singer wrote and produced and is currently at No. 23 on the R&B/Hip-Hop Songs chart. The title track will hit radio as the disc's second single on November 22, while a holiday-themed remix, "Love Letter Christmas," will also be released.

"Love Letter" caps off a year in which Kelly released the official World Cup anthem "Sign of a Victory" as well as "Epic," a greatest-hits compilation issued exclusively in Europe. "Untitled," the singer's last full-length released in December 2009, has sold 334,000 units, according to Nielsen SoundScan.

(Editing by Bob Tourtellotte)

Health reforms trigger spending shift

WASHINGTON (Reuters) – New U.S. reforms are poised to dramatically shift the nation's healthcare spending, not only curbing Medicare costs but also pumping more money toward the private sector as roughly 32 million people gain coverage.

Although the law has little impact on overall healthcare spending, government researchers said they expect sharp changes in the U.S. healthcare sector as the bulk of the recently passed law starts taking effect in 2014.

The survey, conducted by Centers for Medicare and Medicaid Services (CMS) auditors and released on Thursday, is likely to fuel the debate over whether the reform law truly reins in healthcare spending, now already more than one-sixth of the nation's economy.

"The overall net impact is moderate," said Andrea Sisko, a CMS actuary who helped analyze the data. "But when you peel back the onion and you start looking underneath the surface, you start to see a much more pronounced impact on payers."

The analysis comes just weeks ahead of U.S. elections seen largely as a referendum on Democrats, who control both the White House and Congress. Reforming the nation's healthcare system was a top domestic priority for the Obama administration, but Republicans have vowed to repeal the law or cut funding if they win enough congressional seats.

Separately, another study obtained by Reuters on Thursday found most U.S. adults are still confused about when to expect health care changes.

CMS' study, published in the journal Health Affairs, updates the agency's earlier analysis from February, this time taking into account final details in the healthcare reform law passed in late March. Researchers analyzed the impact of the reforms using modeling to project people's behavior on coverage and spending.

Factors contributing to lower costs include reduced payments for most Medicare services and doctor visits as well as cuts to private Medicare Advantage insurance plans, although a provision to cover more of Medicare patients' drugs will increase spending.

Additionally, millions of people are expected to gain health insurance. By 2019, nearly 93 percent of the U.S. population should have coverage, researchers said. Now, more than 40 million people in the United States lack insurance, but that figure would drop by 32.5 million, the study found.

LARGER DEMAND FOR SERVICES

"There's definitely going to be a larger demand for services in 2014," said John Poisal, deputy director for CMS's National Health Statistics Group that made the projections.

That year is when the bulk of the health reforms take effect, including a provision that requires Americans to buy health insurance or face fines.

Most uninsured will gain coverage through expanded joint federal-state Medicaid programs for the poor or on their own through state-based exchanges.

Nearly 16 million people will buy health insurance from private companies through the exchanges in 2014, growing to more than 30 million by 2019, the study showed. That would nearly double the amount of money spent on healthcare for such consumers while also helping to reduce prices, it said.

Provisions that set up immediate insurance coverage for high-risk patients and requirements to extend coverage to young adults up to age 26 are expected to cost $10.2 billion through 2013.

Out-of-pocket expenses are also expected to rise amid new excise taxes on high end, so-called Cadillac health insurance plans and employer cost shifting to workers, CMS found.

Despite the underlying shifts, however, U.S. healthcare costs will continue to rise considerably, reaching $4.6 trillion by 2019 from $2.6 trillion in 2010. That amounts to 19.6 percent of the nation's Gross Domestic Product. Healthcare is already expected to reach 17.5 percent of GDP this year.

It is still unclear how people and businesses will react to the changes, and whether there are enough doctors and facilities to absorb any increased demand.

"It will take at least three years for the market to fully react to the coverage options," the authors wrote.

Overseeing all the reforms also carries a hefty price tag.

Doing so is expected to cost U.S. states -- which are charged with running new health insurance exchanges to help consumers shop for private coverage -- some $37.7 billion through 2019.

At the federal level, administering the reforms will cost the Department of Health and Human Services an additional $2.4 billion.

(Editing by Philip Barbara)

Judge OKs Kodak's settlement of race-based lawsuit

ROCHESTER, N.Y. – A federal judge on Friday approved Eastman Kodak Co.'s $21.4 million offer to settle class-action lawsuits by black employees who maintained white counterparts were favored over them for pay and promotion.

In an almost seven-year legal tussle, U.S. Magistrate Jonathan Feldman signed off on a deal that pays about 3,000 current and past Kodak workers amounts ranging from $1,000 to $50,000. The decision ends a 2004 class-action lawsuit and a similar suit filed by other black workers in 2007.

The Rochester, N.Y.-based photography products maker was accused of paying black employees less than white co-workers, passing them over for promotions and maintaining a racially hostile work environment.

Last October, Feldman heard arguments in favor of the deal from Kodak and lawyers for the plaintiffs. He then fielded complaints from more than a dozen former employees who said proposed payouts were inadequate, lawyer fees too high and the offer unfairly excluded workers who left Kodak before 1999.

Under the settlement, 3,008 workers get $9.65 million and their lawyers $9.7 million in fees and expenses. Adjustments to individual awards were negotiated, with a dozen workers having $75,000 awards reduced by one-third.

The balance of the settlement will go to administering the claims and supporting enhanced diversity training for supervisors that Kodak promised as part of the deal. The company will also hire an industrial psychologist and two labor statisticians to review pay and promotion policies and recommend improvements.

In a statement, Kodak said the settlement "represents a resolution of mutual interest and it absolutely does not suggest any wrongdoing" on the company's part.

"Kodak is widely recognized as a company committed to creating and maintaining an inclusive workplace in which all employees are valued, treated fairly and can contribute to their full potential," it added.

The judge noted that a Kodak damage expert, Harvard University Professor David Bloom, analyzed historical payroll data and concluded "there were no race-based disparities in promotion and compensation at Kodak between 1999 and 2005 and African-Americans were, in fact, statistically favored in promotion and base salary increases during the 1999-2005 time period."

"These risks and others make the fairness of the settlement all the more evident and weigh in favor of approving the settlement agreement," the judge said in a 59-page decision.