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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NLC: Women's Clothing Lines for Nygard/Dillard's, J.C. Penney and Wal-Mart Linked to Human Trafficking in Jordan Sweatshop

/PRNewswire/ -- Self-described as the "number one sportswear manufacturer in Canada," Peter Nygard's women's clothing is sewn at the International British Garments (IBG) factory, where 1,200 guest workers from Sri Lanka, Bangladesh and India -- 75 per cent of them young women -- have been trafficked to Jordan, stripped of their passports and held under conditions of indentured servitude, according to a new report from the National Labor Committee.

Charles Kernaghan, director of the U.S.-based National Labor Committee, whose report on IBG "Dirty Clothes," is being released today, said that, while sewing Nygard International Ltd.'s Alia, Tan Jay, and Investments labels, the women are forced to work 16-hour shifts, from 7 a.m. to 11 p.m., seven days a week.

"There are also mandatory, all-night 23-hour shifts, from 7 a.m. to 6 a.m. at least once a week," Kernaghan said. "The exhausted workers are at the factory over 110 hours a week, while being cheated of over half the legal wages due them. Instead of earning the 74.5-cents-an-hour minimum wage in Jordan, they are paid just 35 cents an hour." Nygard International's clothing is also sold at Dillard's in the U.S. J.C. Penney and Wal-Mart are beginning production at the IBG plants.

"When workers ask for the return of their passports and to be paid correctly, they are slapped and threatened with forcible deportation," said Kernaghan "There are also serious allegations of sexual harassment, even rape, and of workers being overworked to death."

Workers are housed in filthy primitive dormitories without heat and with only sporadic access to water for two hours, three or four days a week. The dorms are infested with bed bugs, and shown photographs of the insects, entomologist Dr. Susan C. Jones of Ohio State University confirmed the bed bugs were engorged with blood.

"All labour laws in Jordan, not to mention the International Labour Organization's (ILO) internationally recognized workers' rights standards, are being blatantly violated at the IBG factory," said Kernaghan. "In fact, the Jordanian Ministry of Labour has placed the abusive IBG plant on their 'Golden List' of best factories."

In a single week, from January 28 to February 17, 2010, Nygard imported more than 280,000 women's pants made at the IBG factory, worth $2.5 million. The customs value of the pants -- the total cost of production and transport -- was $9.49. Many of the pants retail for $38, which represents a 300-percent mark-up. The workers were paid nine cents for each pair of pants they sewed.

Kernaghan said workers do not want Nygard and the other companies to cut and run, pulling work from the factory, which would only further hurt the workers who have already suffered enough. All workers are asking is that their legal rights be respected.

The IBG sweatshop in Jordan is owned by G4S, the world's largest security service company, which also operates in the U.S.

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HPV Vaccine Study Shows Why Few Women Getting Shots

TT Note: Gotta admit it. The massive advertising did encourage questions in my mind, but it was advertising.

/PRNewswire/ -- Sales of Merck's HPV vaccine, Gardasil, declined by a third this year, and three years after the FDA approved the drug an estimated three out of four women remain unvaccinated -- despite millions spent on advertising and lobbying for government mandates. A recent marketing study offers a reason.

Michelle Steward, assistant professor of marketing at Wake Forest University, and several colleagues conducted an experiment with women, ages 18 to 30, and found that they were more likely to consider being vaccinated for HPV after participating in a survey than as a result of commercial advertising or a government mandate.

"The educational cues in the survey are the least coercive and appear to prompt more thinking about the risks of not being vaccinated than laws, which may produce a negative backlash or advertisements, of which consumers might be skeptical," said Steward.

"The results would suggest that Merck's money may be best spent engaging people through a survey on relevant health topics to get the consumer to think about their own risks. There's nothing to suggest that there would be any difference in males' reactions. If Merck gains FDA approval to market Gardasil for boys, the advantages of surveys versus mandates or advertising would remain the same.

"Determining how best to move consumers from hearing about a drug or vaccination to actually using the product should rival R&D in importance to a firm," Steward said.

The study, "The Influence of Different Types of Cues-to-Action on Vaccination Behavior: An Exploratory Study," will be published in the spring edition of the Journal of Marketing Theory and Practice.

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Long-Term Care: The Next Big Women's Issue?

/PRNewswire/ -- Long-term care is getting a lot of exposure in the current health-reform discussions, but we ain't seen nothin' yet, according to Denise Gott, Chairman of the Board of LTC Financial Partners LLC (LTCFP) -- http://www.ltcfp.com/ -- one of the nation's largest and most experienced long-term care insurance agencies. "Wait until the most-affected individuals get wind of what's in store for them; all hell could break loose," she says.

And who are those individuals? The millions who succumb to longer-lasting illnesses and injuries, requiring help with eating, toileting, dressing or moving around?

"No," says Gott. "It's the women who end up caring for them. They're the ones suddenly forced to provide 24/7 assistance to their husband, parent or other loved one who can't function on their own anymore." A majority of women will eventually need long-term care themselves, "but they tend to live longer than men, and social norms still consign females to the care giving role. So they're the ones who have to sacrifice their futures when they're still relatively young and fit, with years of productive, enjoyable life still to live."

Long-term care insurance would free women from this forced care giving, since it provides funds for professional nursing home or in-home care, "but the vast majority of women have no long-term care buffer. No policy for their husband or mother or father, let alone for themselves." Ordinary health insurance doesn't cover long-term care, nor does Medicare. Medicaid does, but only for the less affluent who lack assets.

The media's recent attention to long-term care centers around the Community Living Assistance Services and Supports (CLASS) Act of 2009, which would create a public insurance program for adults who become functionally disabled. "But the benefits would be less than half of those provided by a typical private policy, and they wouldn't kick in for five years," Gott says. "This could be better than nothing for lower-income people, but inadequate, in my opinion, for the middle class. Women would still be saddled with significant care giving chores."

A better solution would be "significant new tax incentives to help people buy private LTC insurance on their own, tailored to their needs," Gott attests. "Women should be screaming about this to their representatives in Congress. Their futures depend on it."

Also, the talk shows should be talking it up, Gott says. "I'm surprised Oprah, The View, and 60 Minutes aren't all over this."

Forced care giving has an economic as well as lifestyle downside. "Household income dwindles whenever a woman has to give up her job for unpaid care duties," says Gott. "Multiply that by the millions of women affected, and think of the drain on the economy. It extends into the billions." Tax breaks for long-term care insurance, "would be a great federal investment, helping us pay for other aspects of health reform."

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Can't Vote or Drink But....

TT Note: Let's see. She can't legally drink, buy cigarettes, get married, or vote, but she can ask for a drug? Anybody ever think that the 17 year old brain may consider taking more of these pills than are safe? Hey, has anyone done the studies to show what that level may be? Perhaps, she'll go grab some for her minor friends, so they, too, can experience the life. Oh, wait, that's right. She's a minor, too.

Updated FDA Action on Plan B (levonorgestrel) Tablets


On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.

Plan B is manufactured by Duramed Research, Inc. of Bala Cynwyd, Pa.

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Federal Court Rules FDA Must Reconsider Plan B Decision

/PRNewswire / -- Today, the U.S. District Court for the Eastern District of New York rejected the Food and Drug Administration (FDA) decision to limit over-the-counter access to the emergency contraceptive Plan B to women over 18, ruling that it was based on politics and ideology, rather than science. The court ordered the agency to reconsider its decision. It also ordered the FDA to act within 30 days to extend over-the-counter access, which is currently limited to 18 year olds and over, to 17 year olds.

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against the FDA.

"The message is clear -- the FDA should put medical science first and leave politics at the lab door. We are encouraged that the agency, now under new leadership, will take that message to heart."

The Center for Reproductive Rights sued the FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women over 18 and only behind the pharmacy counter. The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

"According to the FDA's own rules, the only legitimate criteria for making a drug available without a prescription are safety and efficacy," said Northup. "Emergency contraception is proven safe and effective and today, all women -- including young women for whom the barriers and the benefits are so great -- are one step closer to having the access they need and deserve."

The Court found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns."

Before its action on Plan B, the FDA had never restricted a non-prescription drug based on a person's age, nor had the Bush Administration ever been consulted by the FDA about an over-the-counter drug application. Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process. Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the Administration's political directives.

Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political "operatives" to making a decision to reject over-the-counter access to Plan B before completion of the standard review.

The Center's battle to make Plan B available over-the-counter to women of all ages began in 2001, when it filed a citizens' petition with the FDA on behalf of over 70 medical and public health organizations to grant the drug over-the-counter status. On January 21, 2005, the Center filed Tummino v. von Eschenbach in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP); National Latina Institute for Reproductive Health; individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy; and parents who seek over-the-counter access for their daughters. On March 30, 2007, the Center asked for summary judgment in the case, arguing that the evidence gathered during discovery made it unnecessary for the court to hold a trial and that the court should order the agency to make Plan B available without a prescription to all women.

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Could Listening to Media Be Harmful to Your Baby?

Media May Have Gotten Alcohol Study Wrong
Claim that pregnant women can drink safely is erroneous, researchers say

December 22, 2008

Pregnancy women shouldn't drink alcohol, health researchers say, despite what may have recently been reported on the effects of moderate drinking and a developing fetus......More

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