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Breast Implants And Lymphoma: New Safety Alert From The FDA

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*

Hope For Those With Body Dysmorphic Disorder

The Science Daily article entitled Body dysmorphic disorder patients who loathe appearance often get better, but it could take years discusses the disorder as highlighted in the Journal of Nervous and Mental Disease (JNMD).  

The JNMD article reports the results of the longest-term study so far to track people with body dysmorphic disorder (BDD). The study was conducted by researchers at Brown University and Rhode Island Hospital. The good news? The researchers “found high rates of recovery, although recovery can take more than five years.”

This is a small study with only 15 BDD patients who were followed over an eight-year span. An excerpt:

After statistical adjustments, the recovery rate for sufferers in the study over eight years was 76 percent and the recurrence rate was 14 percent. While a few sufferers recovered within two years, only about half had recovered after five years.

The subjects were a small group diagnosed with the disorder out of hundreds of people participating in the Harvard/Brown Anxiety Research Project (HARP). Study co-author Martin Keller, professor of psychiatry and human behavior and principal investigator of the HARP research program which has been ongoing for more than 20 years, said that because the BDD sufferers were identified through this broader anxiety study, rather than being recruited specifically because they had been diagnosed with BDD, they generally had more subtle cases of the disorder than people in other BDD studies. In comparing the HARP study with the prior longitudinal study of BDD, it is possible that the high recovery rate in the HARP study is due to participants having less severe BDD on average.

 About body dysmorphic disorder:

— In its simplest definition, it is an obsessive preoccupation with a slight, imperceptible, or actually nonexistent anatomic irregularity to the degree that it interferes with normal adjustment within society. Read more »

*This blog post was originally published at Suture for a Living*

Breast Implants: A Geographical Comparison

This article (full reference below, free access) came to my attention via MDLinx. It was interesting to read. The conclusion verified my expectations rather than surprised me.

The authors conducted a retrospective review of patient demographics and implant information from three university settings: Kelowna (British Columbia, Canada), Loma Linda (California, USA), and Temple (Texas, USA). Each cohort included 100 consecutive breast augmentation cases. Characteristics analyzed included age, height, weight, BME, parity, and average implant volume. 

When considering the 300 as one cohort, the average age was 34 years with a height of 163 cm (5’4”), weight of 58.1 (127.8 lb) and parity of 1.7 . The average implant size was 370 ml. Read more »

*This blog post was originally published at Suture for a Living*

Doctors, Voicing Concerns, And Fear Of Retaliation

Shouldn’t it be possible to voice a concern about a medical treatment, procedure, or claim without the fear of retaliation? If the claims are backed by science, then simply addressing my concerns would be enough.

Fear of retaliation silences discussion. Fear of retaliation makes it difficult to do the “right thing” when the public or an individual patient is at risk.

This incidence involves a British plastic surgeon threatened with libel action by the ‘Boob Job’ cream’s manufacturer after she voiced concerns/doubts of its effectiveness. Sense About Science has a great summary of the entire affair: “Plastic surgeon threatened for comment on ‘Boob Job’ cream.” Read more »

*This blog post was originally published at Suture for a Living*

Stem Cell Face-Lifts?

It’s been almost a month since the LA Times ran the article by Chris Woolston entitled  The Healthy Skeptic: Stem cell face-lifts on unproven ground. It’s well written and presents a fairly balanced view. While I am a fan of stem cell research, I think the “claims” are often put ahead of the science.  This is one of those times. I can’t find any decent articles to support the claims of the plastic surgeons doing “stem cell face-lifts.”

My view is echoed in the article (bold emphasis is mine):

Rubin says he’s excited about the potential of stem cells in the cosmetic field and beyond. Still, he adds, there are many unanswered questions about the cosmetic use of stem cells, and anyone who claims to have already mastered the technique is jumping the gun. As Rubin puts it, “Claims are being made that are not supported by the evidence.”

While researchers in Asia, Italy, Israel and elsewhere are reporting decent cosmetic results with injections of stem cell-enriched fat, Rubin says that nobody really knows how the stem cells themselves are behaving. He points out that fat injections alone can improve a person’s appearance, no stem cells needed.

Rubin believes it’s possible that injected stem cells could create new collagen and blood vessels — as they have been shown to do in animals studies — but such results have never been proved in humans. And, he adds, the long-term effects of the procedures are an open question.

Stem cell face-lifts could someday offer real advances, says Dr. Michael McGuire, president of the American Society of Plastic Surgeons and a clinical associate professor of surgery at UCLA. But he believes that scientists are still at least 10 years away from reliably harnessing stem cells to create new collagen and younger-looking skin. Until then, promises of a quick stem cell face-lift are a “scam,” he says.

The American Society for Aesthetic Plastic Surgery (ASAPS) issued a statement two weeks after the article first appeared. Read more »

*This blog post was originally published at Suture for a Living*

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