The November issue of the journal, Annals of Plastic Surgery, features an up to date comprehensive review article on the state of research involving issues of safety surrounding silicone gel breast implants. Researchers from the Vanderbilt University Medical School-Ingram Cancer Center review several hundred related studies to produce this magnum opus. A story interview the lead researchers can be read on the Vandy News Service here.

This "snapshot" is the most thorough review of this topic since the landmark 1999 Institute of Medicine report and addresses the ongoing epidemiology studies thru the Fall of 2007. The body of literature continues to be remarkably consistent in that the weight of the epidemiological evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurological diseases.

From lead author, Dr. Joseph McLaughlin,

“Few implantable medical devices have been investigated for safety hazards more extensively than silicone gel-filled breast implants,” said McLaughlin. “For almost three decades researchers around the world have been conducting in-depth studies on the health of women with implants to determine if there are significant health risks. The evidence is clear that implants are not linked to serious disease.”

An increased suicide rate from patients implanted 20-30 years ago has been the only consistent finding across several large follow-up studies. I've touched on that issue before on Plastic Surgery 101 (read here) on how inferring causation is likely incorrect as epidemiology suggested significantly higher psychiatric co-morbidity among women in those studies from the 1960's to early 1990's (so you'd expect higher suicide rates/attempts). I cannot imagine how you could ever effectively study this subject prospectively, particularly in the United States where medical records aren't centralized. Confusing things even more I'd submit is the recent rise in the United States of pharmacological treatment with mood-altering drugs (Prozac, Daypro, Xanax, anti-depressants, ADHD drugs, weight-loss medicines, etc...) for people who don't have classic or formally diagnosed depressive disorders. I see women (and men) all the time on such medicines prescribed by their family doctor or internist who would not meet strict medical criteria for what they're medicated for.

It would seem to me at this point that the most important issues left to characterize about existing silicone implants would be:

1. Late rupture rates - what can we expect durability-wise at 12-15+ years out?
2. Suicide rates - how to most effectively screen out unstable patients?
   
   

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The image at right is by artist Sheila Chambers entitled "Before Suicide"

It's funny the way the media seizes on medical issues sometimes. In late July, another analysis of suicide rates among breast augmentation patients was published and it generated enough attention to percolate thru most media services. This study was (I think) the 5th or 6th epidemiological study in the literature flagging breast augmentation as a risk factor for suicide. I wrote about this before here & here, discussing this issue in context to what we do know.


These kind of hyped stories about breast implants inevitably generate questions from patients in the week or two after they break. They're also siezed upon by activists in the breast implant debate as a priori evidence that implants are evil, predictably generating a slew of implausible theories about how breast implants must be causing ______ (cancer, autoimmune disease, suicide, global warming, etc.....)


In the July Annals of Plastic Surgery published a Swedish study titled, "Excess Mortality From Suicide and Other External Causes of Death Among Women With Cosmetic Breast Implants". Almost 3,527 women out of Sweden were followed from as far as forty plus years ago (1965-1993), and what was observed was that there's an increased risk of suicide in women, especially 10 years after the implant surgery.

How big are the numbers we're talking about? Of 175 deaths among study participants, 24 were suicides which was something like twice the expected 12 if you assume that this group was similar to the population as a whole. However, this group of patients is clearly NOT representative of the larger pool of women for risk factors for suicide. In fact, one researcher working "backwards" from suicide rates towards known risk factors suggested that in fact an expected 5x increase in suicide rates should have been observed and speculated that the surgery had actually lowered observed rates of suicide. I don't buy that neccessarily, but it's an interesting hypothesis.

So what are the problems with trying too read much into this if you're asserting some causal relationship?

1. The group of patients and cultural norms in 2007 are arguably different from a group of patients nearly 30-40 years ago. As surgery has become more "democratized" (ie. more people can afford it) and plastic surgery is more mainstream, I'd bet you'll see a dilution effect somewhat down the line as the % of high risk patients shrinks relative to the numbers undergoing the procedure.


2. These databases from (mostly) western Europe don't include patients who were implanted for breast cancer reconstruction or who had surgery done by non plastic surgeons. We have not observed increased rates of suicides in implant breast reconstructions.


3. The largest one of these kind of studies saw differences in suicide rate disappear when the control group was other cosmetic surgery patients rather then the population as a whole.


4. Several dozen large studies have failed to establish any clear mechanism for breast implants causing systemic disease. The United States, Canada, Great Britain, and the European Union have all reaffirmed their positions on this in the last 18 months.


5. These studies weren't designed to prospectively study suicide rates and offer few clues as to the nature of the relationship between breast implants and suicide.

Like several other studies in this area, they found problems with an increased number of women who were substance abusers, alcoholics and had underlying depression. In fact, they found almost a 3x greater rate of deaths attributed to alcohol or substance abuse, or attributed to accidents or injuries that could have been associated with alcohol or drug use.

What's a plausible "wild card" in the mix? Body dysmorphic disorder (BDD). Defined as a preoccupation with a slight or imagined defect in appearance that leads to significant psychological distress, BDD has been found in up to 5%–15% of all cosmetic surgery patients. These patients bring rates of suicidal ideation and suicide attempts that are 10x higher (or more) to the table.

Meredith Vieira discussed the study on the Today show last week with NBC's chief medical editor Dr. Nancy Snyderman who had an excellent summary of this study and how it's applied in day to day practice,

"Now, is this great science? No. Is there sort of an implied link? Maybe. But I don't think this is an indictment of plastic surgery and certainly not breast implants. It may be that if you'd roll back to the '60s when doctors really started doing a lot of these, they weren't screening patients so well. And if a woman has unrealistic expectations or she's psychiatrically not sound, she's not a good surgical candidate. And I think in 2007, you'll have doctors screen plastic surgery patients much differently than they did 30 or 40 years ago...

Good surgeons say no because they don't want problem patients on the back end. If you have a patient with unrealistic expectations, you're going to have a patient who will be unhappy with you forever and ever. And no surgical fee is worth that. So you look at the good--the good plastic surgeons, they're always trying to get the temperature of patients and what they expect, and they'll tell patients no"

Rob

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The correlation between patients with breast implants and slightly higher suicide rates is something I touched on previously (see here).

To most observers this is a fairly easy phenomena to explain: higher rates of psychiatric issues and depression among cosmetic surgery patients would expect to result in a corresponding suicide rate increase. An excellent review of this literature was published in the February issue of Plastic & Reconstructive Surgery, the world's flagship scholarly journal for Plastic Surgery.

Still, among the cadre of anti-implant activists , there lingers the suggestion that these observed suicide rates are from either psychic or physical pain from their implants. This was voiced recently by the actress/ant-implant crusader, Sally Kirkland (see photo), who speculated that Anna Nicole Smith's death by drug overdose was from her breast implants. (As opposed to her reported history of depression, psychiatric problems, alcoholism, and drug abuse/dependency.)

"Dr." Kirkland's observations aside, an interesting addition to the literature popped up this week which asked the logical question of whether the increase in suicide rates was also seen in breast cancer patients. Surprising no one, the answer is no in a National Cancer Institute funded review of cancer registries. The skeleton of this study can be read here.

Hopefully this puts the stake in the flawed assertion that breast implants causes suicide, and redirects the attention towards more effective screening out of potential patients who would benefit from psychiatry rather then surgery.

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A trend has been identified in several studies of patients with implants which briefly merited some attention last summer, namely that increased suicide rates has been observed among implant patients in some of the large European databases.




Does this suggest that implants actually cause suicide? Absolutely not.

Rather, it likely reflects selection bias (a phenomena where accurate conclusions from statistical analysis is undermined) in the studied patient groups.

What's that in this instance?
An increased incidence of mental illness and depression among prospective patients.

One of the Danish studies reported that the women with breast implants had almost double the rate of psychiatric morbidity as those in the control groups. This data is easier studied in countries with centralized health care as exists in Canada & Western Europe, and is where most of this information comes from.

It has been suggested that a psychiatric condition, body dysmorphic disorder may explain the elevated suicide risk among breast implant recipients. Earlier research from the University of Pennsylvania Center for Human Appearances (Yes, there actually is such a thing!)suggested that as many as 15% of cosmetic surgery patients have the condition, characterized by preoccupation with small or imagined defects in appearance.

About 80 percent of breast implants in the United States are for cosmetic reasons and 20 percent for breast reconstruction after breast cancer surgery. Dr. Leroy Young, a Plastic Surgeon from St. Louis,one of the world's experts on silicone implants and a respected basic scientist speculated a few years ago that the data trickling in may in fact no longer be applicable to today's breast augmentation patient

“In the 1960s and '70s, women in the U.S. who had breast augmentation tended to smoke, drink alcohol, and report other risk-taking behaviors more often than the general population, but our findings suggest that this is no longer the case,”.

A recent survey of 5,000 women in the U.S. who had either received breast implants or were considering them found that the women were less likely to drink alcohol and smoke than the general population. Young says these women had a lower frequency of signs of depression than did the earlier generation of American implant recipients and the women in the European studies.

Is there a plausible explanation for breast implants causing suicide?
Not really. Some anti-implant activists are suggesting something along the lines that implants cause so much psychic or physical pain that it must be driving these women to killing themselves.

Jacques Brisson, M.D., D.Sc., of Laval University in Quebec City and lead author of the largest study which has noted this phenomena had this to say:

"Recently, it was suggested that complications experienced by women who received breast implants could contribute to increased despair, which may increase the chance of suicide," the authors said.

However, our findings to not support this hypothesis because we found no increase in the standardized mortality ratio for suicide with increasing length of follow-up," they said. "Additionally, there were no differences in suicide rates between implant patients and other plastic surgery patients."

The most recent such study, presented by Dr. Brisson, was performed in a population much larger then the others in a group of Canadian women. (see here for a blog entry I did on this last summer) Like the other work, there was an elevated suicide rate. However, the suicide rate was similar to that of women who had other cosmetic plastic surgery procedures which further strengthens the belief that breast augmentation (and indeed all cosmetic surgery) has a correlative relationship to depression/mental illness rather then a causative one to suicide.

Will today's patients have similar such rates or will observations like Dr. Young's ultimately prove correct. Check back in 10-15 years.

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