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FDA Reports On Association Of Breast Implants And A Rare Form Of Cancer

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The FDA [has] issued an alert about a pos­sible link between breast implants — saline or sil­icone — and a rare form of lym­phoma called anaplastic large cell lym­phoma (ALCL). These lym­phoma cases are exceed­ingly rare, but the asso­ci­ation appears to be significant.

The FDA iden­tified a total of approx­i­mately 60 ALCL cases in asso­ci­ation with implants, worldwide. Of these, 34 were iden­tified by review of pub­lished medical lit­er­ature from 1997 to May, 2010; the others were reported by implant man­u­fac­turers and other sources. The agency esti­mates the number of women worldwide with breast implants is between five and 10 million. These numbers translate to between six and 12 ALCL cases in the breast, per million women with breast implants, assessed over 13 years or so.

In women who don’t have implants, ALCL is an infre­quent tumor, affecting approx­i­mately one in 500,000 women is the U.S. per year. This form of lym­phoma — a malig­nancy of lym­pho­cytes, a kind of white blood cell — can arise almost any­where in the body. But ALCL cases arising in the breast are unusual. The FDA reports that roughly three in 100,000,000 women are diag­nosed with ALCL in the breast per year in the U.S.

These are very small numbers. Still, the finding of ALCL tumors by the implant cap­sules is highly sug­gestive. Almost all of the implant-associated ALCL cases were T-cell type, whereas most breast lym­phomas are of B-cell type. The lym­phomas arose in women with both sil­icone and saline-type implants, and in women with implants placed for pur­poses or aug­men­tation and for recon­struction after mastectomy. Read more »

*This blog post was originally published at Medical Lessons*

State Of Healthcare In The Union

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Short and sweet. That’s how President Obama addressed healthcare reform in his State of the Union address [Tuesday] night. In less than 700 words, he outlined how he’d improve but not retreat on what’s been enacted into law.

He’s willing to work on changes, he said, naming malpractice reform and reducing onerous paperwork burdens for small businesses. But, he cautioned, “What I’m not willing to do is go back to the days when insurance companies could deny someone coverage because of a pre-existing condition.”

President Obama had invited two real people to his address to highlight the law’s successes. One is a brain cancer survivor who can access health insurance through high-risk pools created by the law. The other is a small business owner who lowered health insurance costs by $10,000 for his nine employees, a probable jab at the “job-killing” title of an attempted yet futile repeal vote last week.

The President’s remarks come at a time when the public is of two minds on healthcare reform. While many state they don’t like the entire package, they also love individual aspects of it. The individual mandate remains widely unpopular, but allowing those with pre-existing conditions to access insurance is widely popular, as does Medicare and Social Security.

The Republican response by Rep. Paul Ryan, R-Wis., Chairman of the House Budget Committee, responded that, “The President mentioned the need for regulatory reform to ease the burden on American businesses. We agree — and we think his healthcare law would be a great place to start.” The House has voted for a repeal and Senate Republicans are preparing legislation and promising to ask for a vote. (Los Angeles Times, Politico, Kaiser Health News, Greenville [South Carolina] Online)

*This blog post was originally published at ACP Internist*

Breast Implants And Lymphoma: New Safety Alert From The FDA

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From the Food and Drug Administration (FDA) safety alert yesterday:

ISSUE: The FDA 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.

BACKGROUND: 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. 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.

While the FDA’s new report is interesting, as it stands it’s of little consequence. A mere 60 cases of a unusual breast cancer worldwide is a tiny number compared to the huge number who develop the much more common ductal breast cancers (about one in seven women in the U.S.) Breast implants have not been found to affect this more common cancer incidence. I do expect this statistic to be misquoted by the anti-breast implant factions online.

As an aside, I do remember a case in a fellow plastic surgeon’s mother of a lymphoma near a breast implant capsule when I was a resident. This is the only breast cancer of this type I have ever seen, however, in 14 years of practice. While I don’t doubt the association, I do focus on the significance of this report to the average breast implant patient, which is very little at this point.

– John Di Saia, M.D.

*This blog post was originally published at Truth in Cosmetic Surgery*

Effect Of Autism-Vaccine Fraud Not Easily Undone

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Eighteen percent of American believe that vaccines can cause autism, 30 percent remain unsure, and 52 percent of Americans don’t think vaccines can cause autism, according to public opinion polling done after research linking vaccines to the condition was reported as fraudulent.

While 69 percent of respondents said they had heard about an association between vaccination and autism, 47 percent knew that the original Lancet study had been retracted, and that recently the research is reported as being fraudulent.

The poll also found that 86 percent of parents who have doubts about the vaccine said that their children were fully vaccinated, compared to 98 percent of parents who believe vaccines are safe, and that 92 percent of children are fully vaccinated.

The poll was conducted after news reports were published that said Andrew Wakefield, the lead researcher of the research linking autism to the MMR vaccine, had used faked data.

More than 20 studies since Wakefield’s have disputed the association between vaccination and autism.

The online survey of 2,026 adults from Jan. 11 to 13 was done by Harris Interactive and HealthDay. (AP/Fox News, CNN, BMJ, WebMD)

*This blog post was originally published at ACP Internist*

Vision Development: The Impact Of 3-D Video Games On Kids’ Eyes

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nintendo3ds Nintendo Warns on 3 D Games for ChildrenLast week, Nintendo became the latest consumer electronics maker to warn that kids shouldn’t use their three-dimensional image-based gaming devices because they may have a negative impact on development of the human visual system.

The warning came just a month before the company’s much anticipated release of the 3DS, which is just such a device that features a 3.5-inch screen which can create 3-D images without the need for special glasses. The 3DS is Nintendo’s most anticipated new product since it released the iconic Wii gaming device in 2006.

Sony’s PlayStation3, a similar product that requires glasses to create the 3-D effect, already carries a similar warning, as do 3-D TV sets made by Sony, Samsung, and Panasonic.

Nintendo’s warning applies to kids that are six years old or younger. The Japanese company advised parents to block access to the game machine’s 3-D mode for these kids, while adding that it was okay for them to use the 3DS in 2-D mode. Read more »

*This blog post was originally published at Pizaazz*

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