Suzanne Somers “grew a new breast” with stem cells plus fat transfer? Not so fast…

One of the very earliest topics of this blog was alternative medicine cancer cure testimonials, a post that I wrote nearly 14 years ago. Basically Suzanne Somers was diagnosed with breast cancer in 2000. She underwent what appears to have been standard breast-conserving surgery (colloquially known as lumpectomy) followed by radiation therapy. However, she refused chemotherapy and hormonal therapy (Tamoxifen) in favor of iscador, a compound made from mistletoe extract. Since then, Suzanne Somers has fashioned herself as an alternative medicine entrepreneur, writing a book about “brave maverick doctors” (i.e., quacks) curing cancer (which is where I first heard about Stanislaw Burzynski) and promoting bioidentical hormones as a veritable fountain of youth. She’s back in the news again with a slew of stories in which she’s claimed to have “regrown” her breast with stem cells. The story hit me like a slap on the forehead. I vaguely remembered having encountered it before, but for the life of me I don’t know why I’ve never written about it before. So I couldn’t resist rectifying that longstanding oversight. First, however, a recap is in order.

I’ve described these sorts of alternative cancer cure testimonials before, and Suzanne Somers’ testimonial falls into a very common category of these in that she accepted standard treatment to resect the cancer, but declined the recommended adjuvant therapy administered after surgery in order to decrease the risk of cancer recurrence in favor of some unproven remedy or quackery or other. Then, when she did well afterwards, still being alive 18 years later, she attributes here good fortune to the quackery rather than the surgery that removed her cancer and the radiation therapy that decreased the risk of its recurrence in the breast or axillary lymph nodes. I’ve documented a number of this particular kind of (usually) unintentionally deceptive cancer cure testimonials, and not just for breast cancer. I say “usually,” because most cancer survivors promoting these narratives aren’t intentionally deceiving; they simply don’t know the difference between adjuvant and primary treatment for their cancer and don’t understand that it was almost certainly the surgery they underwent that cured their cancer.

Basically, most of these purveyors of cancer cure testimonials had cancers that had a high probability of being cured with surgery ± radiation alone but a higher probability of being cured if chemotherapy or other systemic adjuvant therapy like Tamoxifen were added; e.g., the difference between an 80% chance of cure and an 87 or 88% chance of cure. True, occasionally you’ll see people who had a much higher chance of dying without chemotherapy, like Chris Wark, but even then they generally don’t have distant metastases, which means that their chances of survival with surgery alone were not that horrible. If you have, for example, a one-in-three chance of surviving five years after surgery if you don’t agree to chemotherapy, choose quackery instead of chemo, and then survive five years, it doesn’t mean that the quackery worked. It means that you got lucky and we just don’t hear from the two out of three people with similar odds who weren’t as lucky as you were.

So, coming back to Suzanne Somers, in brief, she had an early stage breast cancer that she had a high chance of surviving even without chemotherapy and that was treated appropriately from the standpoint of controlling the local disease using surgery and radiation. She chose mistletoe extract and did well, believing her good outcome due to the quackery more than the surgery. Since then, she’s been expressing regret at having undergone radiation therapy, even appearing in a video for cancer quack Ty Bollinger’s The Truth About Cancer series in 2015:

This brings us to now, with a stories popping up this week with titles like:

What amazed and embarrassed me is that this is not new information. Indeed, I sense a Breast Cancer Awareness Month-linked promotional campaign going on here, because stories about Suzanne Somers’ “stem cell” reconstruction of her breast first started popping up in 2011 in the anti-aging stem cell underground. For example, here’s an article from 2011 in Life Extension Magazine in which she’s interviewed about her “new breast.” Here’s an article in The Doctor Weighs In from 2012 about Somers’ procedure. She even appeared on The Doctor Oz Show in December 2011 in a story that took up most of the episode entitled Suzanne Somers: The Revolutionary Surgery to Rebuild Her Breast. How on earth had I never written about this before?

She was even on ABC News Good Morning America:

I was intrigued by her claim in this that she volunteered to be “patient number one” in the clinical trial of a new stem cell reconstruction method for her breast, in which she further claimed that she was the first patient to “legally regrow her breast.” Equally annoying was the chipper false balance in which Somers’ embrace of quackery was portrayed as brave and just another choice.

So what’s going on here? And why is Suzanne Somers suddenly popping up all over the media to warm over a story that’s nearly seven years cold? I’m not sure I can answer the second question, but, since I’ve never looked in depth at Suzanne Somers’ claims regarding her breast reconstruction with stem cells, let’s look at her claims.

I’ll start with the story that brought Somers’ claims to my attention:

Wow! Suzanne Somers claims that alternative medicine after breast cancer helped her ‘regrow’ her own breast — no reconstructive surgery needed. Here’s what happened.

After bring diagnosed with breast cancer in 2000 and successfully beating the disease, actress Suzanne Somers, 71, wanted to replace the breast that was left disfigured after treatment. A proponent of alternative medicine, Suzanne famously denied chemotherapy, instead undergoing radiation and a lumpectomy. She said at the time that after surgery, when the bandages were removed, “sixty-five percent of my breast was gone. I had a DD on one side, and on the other side I could barely fill a B cup.” When it came to fixing it, Suzanne took a non-traditional approach to her health again. She underwent a controversial procedure involving stem cells in 2012 — and look at that! Six years later, her breast is back to normal, she said in a new interview!

So can something like this happen after lumpectomy plus radiation therapy? In short, yes. If the lumpectomy is large enough, if it takes enough of the breast, then the tissue volume loss can create asymmetry. Radiation makes things worse, too. While in the short term the breast will swell immediately after radiation due to inflammation, over the long term it will shrink over the months after radiation, and I warn my patients of this. However, for most women the asymmetry isn’t that noticeable or bothersome. One thing that struck me about this story is Somers’ claim that two thirds of her breast was gone. That claim makes little sense; if removal of her cancer required the removal of two thirds of her breast, then she wasn’t a good candidate for breast conserving surgery in the first place and her surgeon should have known that. Presumably Somers could afford the best surgeons; so there’s something fishy about her story, at least from my perspective as someone who does this surgery for a living, especially given that she states that she had a DD cup and has told Dr. Oz and revealed elsewhere that her tumor was 2.4 cm in diameter. I scratch my head at how removing a tumor that, while not small, was not very large located in a DD cup breast. I hate to second guess without knowing more, but the first word that came to mind when I read this was “hack.” I didn’t want to judge, though, based on just this account, and I was right not to do so, as you will see when I discuss her appearance on The Dr. Oz Show.

In any event, Suzanne Somers was not happy with her cosmetic result, which, admittedly, sometimes happens after breast conserving surgery, and wanted to do something about it. However, she didn’t want an implant or flap reconstruction:

But there was one nagging reminder: “To look even when I went out, I wore a prosthetic in my bra that would push up what little I had,” says Somers. “A couple of times it slipped out. I looked down and there was something around my waist that shouldn’t be there! It was mortifying.” Still, the star never opted for implants or a TRAM flap reconstruction, in which muscle, fat and blood vessels from a woman’s lower abdomen are transferred to her breast. Along with post-op scarring, “the look is not natural,” she says. “I told my doctor, ‘Something better will come along.’”

So I looked for this clinical trial on ClinicalTrials.gov. I couldn’t find it. The closest I could find was this trial, NCT02116933. It sounded similar, but it hadn’t been posted until 2014, well over two years after Somers underwent her procedure. I went around looking for other trials testing stem cell-augmented fat grafting for micromastia by any principal investigator. I couldn’t find any. So I searched PubMed to see if Dr. Joel Aronowitz, the surgeon who did the stem cell procedure on Somers, has published his results. I mean, it’s been nearly seven years since the procedure, and the People article I cited above states that there had been ten patients after her. Plenty of time to publish has passed. I found several publications on the isolation of human adipose stromal cells and only one paper on the use of these cells in fat grafting and one review article about the use of these cells. I searched PubMed for the ClinicalTrials.gov number (NCT02116933) of the trial I did find, and found no publications. This review article from 2017 includes the clinical trial in a table, but reports no results. It also listed several references from the Japanese group whose work apparently inspired Dr. Aronowitz. Finally, I noted that several publications were listed on the trial’s ClinicalTrials.gov entry, but none of them appeared to be the reporting of the results, even though the primary completion date was listed as March 2016.

I don’t know what’s going on here, but it’s very odd that I can’t find this clinical trial anywhere. It set my skeptical antennae twitching, and Dr. Aronowitz has a very slick website advertising his cosmetic surgery and services.

I note that he doesn’t mention his clinical trial or Suzanne Somers in his description of the stem cell services offered:

Dr. Aronowitz created the University Stem Cell Center to advance research into stem cell application and help provide this option to patients as an alternative to breast implants. The use of stem cells in breast augmentation is less invasive than the placement of breast implants. Dr. Aronowitz often uses stem cell injections for patients who have previously had implants removed and want an alternative replacement. Stem cells can also be used in breast reconstruction, to reduce the look of wrinkles on the face, to quicken healing time for many types of surgery and more.

Again, I find it very odd that Dr. Aronowitz apparently hasn’t published his results from his “clinical trial” involving Suzanne Somers yet. Maybe I missed it, but I looked in all the usual places. I did, however, multiple videos on Suzane Somers and her reconstruction, for instance this interview, which looks as though it came from around 2012:

Of note, Somers calls it my clinical trial. Not a clinical trial. My clinical trial. That struck me as odd. Maybe it’s nothing and just how she refers to the clinical trial in which she was supposedly a subject. Maybe it means she funded the trial. I couldn’t find anything to clear up my confusion and tell me one way or the other.

In any case, this procedure was first developed by a Japanese surgeon, Keizo Sugimachi, MD, PhD in Japan. His idea was that the addition of stem cells from the stromal-vascular compartment would both secrete factors to keep the fat cells alive and help to form blood vessels to feed their oxygen and nutrient needs. In a series of 21 patients, he reported in 2007 at the San Antonio Breast Cancer Symposium that breast tissue thickness significantly improved in all patients by one month postoperatively. Also, the improvement did not significantly decrease over the next 12 to 18 months. There was also a clinical trial in several European centers. (I note that no results are posted for this trial, either, and PubMed reveals no publications.)

So what’s really going on? First, let’s go back to another article:

Plastic surgeon Dr. Joel Aronowitz removed about 1000 ccs of fat from Somer’s stomach (the equivalent of roughly four soda cans) via liposuction. He then harvested stem cells from half of the fat and combined them with the remaining amount of fat. The mixture was injected back into Somer’s right breast until it filled a C cup. Somers then had her left breast reduced from a DD to match. The 2 1/2 hour process costs between $14,500 and $19,500 (insurance kicks in if the surgery is a reconstruction) and is part of a clinical trial open to women looking for breast reconstruction or enlargement. For more information, go to hollywoodpresbyterian.com.

So the results, if you look at them critically, were a heck of a lot less impressive than the whole “growing a new breast” narrative would leave one to believe. For one thing, to get her breasts to match, Suzanne Somers had to get her unoperated on breast reduced significantly to make them match. In other words, a whole lot of PR and exaggeration appears to be going on here. Indeed, Dr. Oz showed a video that Somers allowed him to show. The angle wasn’t great, but I must admit that I wasn’t very impressed by the difference in size between her breasts. The right breast appeared smaller, but no way did it appear as small as Somers routinely leads everyone to believe. Yes, she did have what I sometimes call a “divot” associated with her scar, but the difference in size before injection of stem cells wasn’t nearly as extreme as I had expected from reading all these accounts of her surgery. From what Somers says, I expected nothing more than just a little nubbin on the right.

Also, we have some evidence now. It’s been nearly seven years. There have been…trials. Reviewing the literature, what most impressed me was how utterly crappy and unconvincing the evidence base for cell-assisted lipotransfer for breast reconstruction after lumpectomy is. While there are some studies, like this mouse study, that suggest that including stem cells with the fat transfer improved the volume retention of the grafting (i.e., the graft didn’t lose volume as much as just standard fat transfer). If you start looking at meta-analyses and systematic reviews, it doesn’t help much. For instance, this systematic review including 11 studies with a total of 336 patients noted a paucity of controlled trials of cell-assisted lipotransfer (CAL):

Due to the infancy of this technique in breast augmentation and reconstruction, the current level of evidence surrounding CAL makes it difficult to draw conclusions for its use in the clinical setting. The majority of studies included in this review are positive in relation to graft retention, complication rates and patient or surgeon reported outcomes. However, there is a lack of methodological rigour – the absence of control groups in eight out of the 11 studies makes it difficult to ascertain the efficacy and safety of CAL. In addition, one of the three studies20, 25 that made use of a control group found no statistical advantage in using CAL in contrast to the other two controlled studies25, 27 that did find a difference. Evidently, further work is needed to assess the full effect, if any, of CAL for this indication. Peltoniemi et al. 201320 highlighted that the conventional autologous fat transfer procedure takes around 90–150 min less time in addition to being $3000 cheaper than CAL. Any benefits that CAL may bring need to be weighed against such drawbacks.

The authors also noted that the studies they examined “demonstrate high levels of bias, lack control groups and display considerable heterogeneity, making the generalizability of study results and effect size unclear,” as well as noting that “lack of long-term follow-up data and associated concerns of malignant risk require mitigation.”

Another meta-analysis, this one from 2016, looked at the use of CAL for more than just breast, noting:

Seventeen articles involving 387 cases were included in the systematic review. The pooled fat survival rate was significantly higher in the cell-assisted lipotransfer group than in the nonlipotransfer group (60 percent versus 45 percent, p = 0.0096). Complication incidence was similar in the two groups. Cell-assisted lipotransfer significantly improved fat survival in the face (by 19 percent) and reduced the incidence of multiple operations (by 13.6 percent). In breast fat grafting, however, fat survival was improved by only 9 percent, which was not statistically significant. Meanwhile, lipotransfer in breast cases was associated with a higher complication incidence compared with face cases (p < 0.001).

Another meta-analysis from 2017 appears to agree, noting no significant difference between CAL and conventional fat transfer in breast, while another meta-analysis from 2018 again noted a higher fat survival rate in the CAL group, further finding:

This benefit of CAL was significant for only injection volumes <100 ml (p = .03). The two groups did not differ in frequency of multiple procedures after fat grafting, but the incidence of complications was greater with CAL than non-CAL (8.4% vs. 1.5%, p = .0019). The CAL method is associated with better fat survival rate than with conventional fat grafting but only for small volumes of fat grafting (<100 ml). Nonetheless, the new technique is associated with more complications and did not reduce the number of surgical procedures needed after the first fat grafting. More prospective studies are required to draw clinical conclusions and to demonstrate the real benefit of CAL as compared with common autologous fat grafting.

The benefit of CAL was only significant for injection volumes below 100 ml (around 3.3 oz)? That sure doesn’t sound that impressive to me. Sure, it could be useful, but it’s far from “regrowing a breast,” the way that Somers and fevered news reports describe things. Most likely, her entire benefit from the procedure that she underwent would have been the same if stem cells had not been used. Certainly, you have to wonder why Dr. Aronowitz hasn’t published the results of his study as far as I can tell. I can’t help but wonder if he’s just doing the same thing that a lot of the stem cell clinics I’ve discussed are doing, selling stem cells as magical cells that can do anything.

Even if CAL turns out to be better than simple fat transfer in randomized clinical trials, the evidence base currently existing doesn’t lead me to believe that it’s likely to be a huge difference. Certainly, there’s no indication in existing evidence that we can expect the inclusion of stem cells with fat transfer will “grow a new breast” the way Suzanne Somers characterizes it. At best, it appears to be a marginal improvement for use in facial reconstruction, if it’s even an improvement at all, and might well have no benefit for breast reconstruction. That’s all for a potentially increased risk of cancer in the reconstructed breast.

As she has been doing for at least 25 years, Suzanne Somers is selling treatments ranging from the dubious to pure quackery. Now if I can only figure out why her tale of “growing a new breast” is popping up in the press other than that it’s Breast Cancer Awareness Month and that she gave an interview at the Carousel of Hope Ball in Beverly Hills on Saturday. Sadly, I suspect that’s all there is to it.