Prophylactic Mastectomy - an ounce of prevention is worth 5% of cure



Sometimes things that are so obviously intuitive still have to be validated. After a number of years of controversy, an increasing utilized surgery to prevent breast cancer is now being shown to be quite effective in both risk reduction and cancer-related mortality. The study "A Population-Based Study of Contralateral Prophylactic Mastectomy and Survival Outcomes of Breast Cancer Patients" is published in the Journal of the National Cancer Institute and can be seen here.

Contralateral prophylactic mastectomy, (CPM), a preventive procedure to remove the unaffected breast in patients with disease in one breast, clearly appears to offer a survival benefit to breast cancer patients age 50 and younger, who have early-stage disease and are estrogen receptor (ER) negative. We've known for several decades that CPM reduced the risk of developing breast cancer, but it was always more elusive to show that it actually saved lives at the end of the day. The practice of CPM has expanded significantly, with >150% growth in the number of such surgeries since the late 1990's.

How effective is CPM? Those younger than age 50 with early stage cancer with ER negative disease had a survival benefit of almost 5% at five years.  For a therapeutic intervention for cancer, 5% is really substantial. You can take it to the bank that following these patients out even farther that we will show increased survival benefit with longer follow-up in the population. This is due to the fact that

  1. the patient's likelihood of getting a second breast cancer in the non-removed breast increases with time
  2. patients with prior breast cancer are among the highest risk group for developing breast cancer

Women older then 50 have a little more complicated decision. In cold, hard actuarial terms you are more likely to die from something else before a new breast cancer would kill you. On the other hand, steadily increasing lifespans of adult Americans has made some of these kind of statistical bets have to be reexamined. I would guess that the reported benefit of CPM gradually increases towards 60 years in future clinical guidelines.

Rob
A recent Canadian study long term follow-up (see here) confirms prior observations that women with breast implants who go on to develop breast cancer have similar outcomes as women without implants who develop cancer. This is more reassurance to our patients about this theoretical concern with implants (ie. that potential difficulty with mammograms would lead to delayed breast cancer diagnosis and worse outcomes). Along a similar vein, women with implants actually have a much lower (~ 40% lower I think) rate of breast cancer as compared to peer groups in the population.

Rob

Slick Deals from Allergan for Botox or Juvederm rebate

One of my favorite shopping websites is Slickdeals (www.slickdeals.net) which is a user driven collection of random shopping deals around the internet. You can find some fantastic bargains on all kinds of things, and the site is updated throughout the day by users reporting sales and promotional items.

In honor of this, I'd like to point out the "slick deal" Allergan is offering on it's products thru July. Allergan is the world's largest breast implant manufacturer, but they also make BOTOX, the dermal filler Juvederm, and the eyelash growing solution Lastisse. Thru July they are offering a $50 rebate coupon on either BOTOX or Juvederm purchases when you try Latisse. Details are available here.



Rob

FDA to mesotherapy - Put up or shut up! (but shut up first)

The FDA last week issued cease and desist orders for a number of clinics offering fat melting "mesotherapy" injections.  The drugs most regularly used in this process are phosphatidylcholine and deoxycholate. Other drugs or products such as vitamins, minerals, and herbal extracts are often mixed into the "gumbo", complicating any assessment of safety or efficacy. Phosphatidylcholine is not approved for injection into your body and has never been evaluated for that use in controlled settings. The new warning shot over the bow went out to six U.S clinics:
  • Monarch Medspa in King of Prussia, Pa.
  • Spa 35 in Boise, Idaho
  • Medical Cosmetic Enhancements in Chevy Chase, Md.
  • Innovative Directions in Health in Edina, Minn.
  • PURE Med Spa in Boca Raton, Fla.
  • All About You Med Spa in Madison, Ind
I would strongly advise people considering using these facilities to think again, as their disregard for patient safety with off label experimentation of these injectable concoctions should signal a general disregard for their patients. As alerts to this FDA warning went out on the ambulance chaser network of websites, expect to see ads shortly recruiting clients for lawsuits.

FYI If you are interested in reading about mesotherapy, I've written several entries about it since 2007 which can be seen here.

Rob

There's no escape from Magical Thinking on health care apparently

There's a good bit of magical thinking around the idea of preventive care. One of the most disingenuous aspects of this is the push for these measures as "free" as part of the health care reform debate. Nothing of value is free, and in health care the overhead propping up the system makes that even more true.

Now there are both cheap and expensive measures that included in what we call preventive care or cancer screening, but at the end of the day they do not save money (even if they may make us healthier). It's actually counterintuitive that some bad habits or diseases from them (smoking or diabetes) may actually save  money as they die younger and end up costing less over a lifetime. That's not a reason to not support early intervention, but it is something that has to be considered when making your countries health care budget.

The truth that the health care costs as a % of GDP are ignored by the bill passed is really scandalous. Facing those true costs was not something the  left was going to let get in the way of entrenching their goal of federal health care. A story about the effects of the health care reform bill I read (see here) seemed to forget that all costs matter until pointed out over and over by readers in the comments section. I thought this one was spot on,

Colonoscopies and mammograms are absolutely not “preventive” care, they are early detection. Having a mammography will not prevent breast cancer any more than owning an umbrella will prevent rain. It may stave off the full and most dire effects of a diagnosis of cancer by allowing early intervention, but that is far from prevention. You will have to pay for the surgery, the radiation, the medication, all the same. Talk about “magical thinking”.
The politics of  telling people NO is complicated and gets caught up in issue driven advocacy groups. A large study from Denmark touched on this obliquely by studying an area of screening efficacy (or lack thereof) when they found no evidence that screening women for breast cancer has any effect on death rates when applied to their countries women in well organized screening programs. For context, breast cancer is the most common cancer in women worldwide, accounting for around 16 percent of all female cancers and is attributed to almost 519,000 people globally each year.

How do other western countries with modern health care systems screen for breast cancer? In Denmark, women are screened every two years from age 50, while in Britain the policy is for women over 50 to be screened about every 3 years. Evidence now suggests that for every 2,000 women who are screened over 10 years, only one stands to have her life saved by the mammogram program, whereas the chance of getting an unnecessary breast cancer diagnosis is 10 times that.



If you'll remember in 2009, we had a hailstorm of controversy here in America when it was suggested that our current guidelines of starting screening mammograms at 40 was neither cost-effective nor evidence-based for affecting breast cancer mortality. There was a lot of ignorant political grandstanding on this as a woman's issue (step forward congresswoman Debbie Wasserman-Schultz D-FL) and Democrat's were furious that this kind of recommendation was coming out during their poorly-conceived sales job on health care reform. God forbid there be any notion that evidence based medicine might infringe upon you right to insist on your ______ (Mammogram, CT Scan, MRI, back surgery, etc....) without considering considering the cost or efficacy. It was a lie then and it's a lie now.

Rob
Nod to LL Cool J in the post title :)

California is an iconic part of the United States that sets many trends. Unfortunately one of these trends is the growth of under or untrained physicians performing cosmetic surgery procedures.

A snapshot of who is performing cosmetic procedures in California, published this month in the journal, Plastic and Reconstructive Surgery, examined 1,876 cosmetic practitioners from San Diego to Los Angeles. Only 495 of them were actually trained in plastic surgery. Primary care physicians with no surgical training to speak of made up the 4th group of liposuction providers following plastic surgeons, dermatologists and otolaryngologists.

Scary, Scary stuff! It seems obvious, but always look for a board certified Plastic Surgeon if you're considering plastic surgery.

Rob

Are your breast implants under warranty?

The New York Times had a story last week (see here) on how expensive orthopedic implants for knees and hips were to replace when they failed. As the cost of the devices themselves (without hospital or physician charges) can run north of $15,000, it can be more then $50K on the price tag when these patients require re-operation for premature failure. Highlighted in the story was the fact that the manufacturers did not expressly provide a warranty for replacement costs of their implants.

Much like these orthopedic devices, patients with breast implants can expect their devices to have to be replaced at some point in their life, either thru device failure or for aesthetic revision issues as their body changes. In contradistinction to the orthopedic companies, both Allergan and Mentor Corp. (whom combined sell 99% of all breast implants in the United States) have offered lifetime replacements on their failed devices for several years now. Allergan in particular has been admirable, as the parent company that makes the implants has been sold twice from it's roots as McGhan medical (later Inamed Corp.). As both Allergan and Johnson & Johnson (owner of Mentor Corp. since 2009) are huge multinationals, it would seem patients with these implants should have a good deal of security of their devices fail for replacement of their implants.

These implant companies do not however cover all other costs associated with the replacement of the devices, but have come up with a fairly generous standard program matched by both Mentor & Allergan

  • 10 years of guaranteed financial assistance
  • Up to $1200 in out-of-pocket expenses for surgical fees, operating room and anesthesia expenses not covered by insurance
  • Silicone filled and saline filled breast implants are both covered
  • Lifetime product replacement
  • Automatic enrollment at the time of your original surgery
Now as a breast implant is relative expensive to design and test clinically, but inexpensive to manufacture by the unit, it's easy to see how these companies can absorb the cost. I don't know exactly their margin per device, but I think it's $600-700+ per silicone implant they sell.

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