Posts Tagged breast cancer
Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29.
We have discussed my misgivings with the 510(k) FDA Clearance before. This Axxent Flexishield product had apparently been given this type of approval by the FDA. Now there are women with tungsten particles within them that had apparently been inadvertently shed from a shield used in the process.
The 510K pathway is a short cut in the FDA approval process for technology that is viewed as substantially equivalent to technology already out there. Calling something equivalent without further study is a judgment call that has a risk element within it. The tungsten particles within the breasts of some of the women who had this treatment are that risk element manifesting itself.
New treatment comes with new and different risks than treatments with a long track record. I tell my patients this each time they tell me of something that is “cutting edge.” There is an edge that cuts for you and an edge that cuts against you. New treatments often do not have substantial understanding of that second edge. When these new technologies have been given abbreviated evaluation by the FDA, people are going to be angry. Some of them are going to sue.
I hope the women with these embedded tungsten particles do not turn out to have significant morbidity. A new uncertainty in breast cancer treatment is not welcome news to any breast cancer survivor.
John Di Saia MD
Breast cancer survivor Suzanne Somers has revealed she underwent an experimental stem cell procedure to reconstruct her breasts. The 65-year-old television icon said the cutting edge procedure used fat cells from her stomach to improve her famous bust line, which was left lopsided after cancer treatment. But the experimental procedure has corrected the problem after surgeons removed fat from her stomach via liposuction and then harvested stem cells from half of it and combined it with the remaining fat. The mixture was then injected back into her smaller breast to fill it up to a C cup. Somers later had the larger breast reduced.
Breast enhancement using autologous (from the patient) fat has been gaining popularity as of late. Interestingly enough in years gone by the American Board of Plastic Surgery deemed it potentially harmful. Fashion changes in plastic surgery just as it does in other areas.
There are several questions with such a technique:
(1) Putting patient harvested fat into breast(s) is associated with some of it degenerating and becoming calcified. This may make mammograms difficult in screening breast cancer. This was by the way one of the more popular criticisms of the technique in the past.
(2) Degenerated fat will also shrink the size of the breast(s) in which the transferred fat is placed. This makes predicting ultimate breast size difficult. When fat degenerates it can also form hard lumps that can make cancer difficult to exclude.
(3) Stem cell harvest may or may not make a difference in any of this. It is unproven ground at present. Stem cell harvest sounds very high tech, but the equally technical question when it is done is how well does it work? What can those stem cells become and how readily do they do that?
None of this is ground-breaking really. Fat transfer is happening. Stem cell technology is improving. We just don’t know the long term ramifications as of yet. I’d rather see a good study with a number of women treated by the technique over a ten year span.
John Di Saia MD
Reader Laura’s Comment:
“The woman in this story was doing Pilates and her breast implant slipped between her ribs. The woman was a breast cancer survivor and had reconstruction surgery with implants after a double mastectomy. What role do you think this played in this happening and how likely will it be to happen again? What could be done to keep this from happening again?”
A cancer survivor has had to have further surgery after her body ‘swallowed’ her breast implant during a Pilates exercise. The 59-year-old from Baltimore, Maryland, had been performing the ‘Valsalva’ manoeuvre when she felt the implant disappear into her body. She was taken to the Johns Hopkins hospital in the city where surgeons found the implant and reinstated it.
I have heard of something like this happening but have never seen such a case. It makes sense that it happened to a breast reconstruction patient. In these cases the tissues are often thin as some of the tissue has been removed with the breast cancer surgery (mastectomy.) The remaining tissue in an implant reconstruction is stretched usually with a tissue expander before a permanent implant is placed.
This amounts to a thin covering of patient tissue housing a breast implant at least on the side of the cancer surgery. A recurrence of this woman’s problem is possible, but might be made less likely by adding some tissue whether it be tissue from the patient (autologous reconstruction) or grafting with an available skin substitute to the thin side. Smaller implants are another option.
John Di Saia MD
Despite the benefits of immediate post-mastectomy breast reconstruction, only a small minority of women, regardless of age, choose this option, a new study indicates. Research has shown that compared with a delayed procedure, immediate post-mastectomy reconstruction improves psychological well-being and quality of life. The new study, headed by Dawn Hershman, M.D., associate professor of medicine and epidemiology at Columbia University Medical Center, indicates that only about one-third of women opt for the procedure, according to the American Association for Cancer Research.
Immediate breast reconstruction does lead to better results in patients with early stage breast cancer. That is a pretty much well known fact. This statistic of less than a third of women seeking this type of reconstruction in this light seems kinda sad, but keep reading:
The study notes that although overall rates of reconstruction have increased since 2000, the greatest increases were seen among women with commercial insurance (from 25.3 to 54.6 percent) and women under age 50 (from 29 to 60 percent). Among women younger than 50 who had commercial insurance, 67.5 percent underwent immediate breast reconstruction. Overall, women with commercial insurance were more than three times as likely to opt for immediate reconstruction compared with women without health insurance.
Well of course women with health insurance are going to be more likely to have breast reconstruction than those without particularly in a recession. Breast reconstruction is expensive and nobody does it for free. The good news is that amongst those who have insurance coverage breast reconstruction (whether immediate of delayed) is on the rise.
Level-headed analysis kinda takes the wind out of the big headline doesn’t it. When reading media takes on study results, it helps to read the studies themselves. Some media outlets are better than others of course.
John Di Saia MD
Giuliana Rancic has revealed she will undergo a double mastectomy, after being diagnosed with breast cancer in October. America’s popular morning show updated its Twitter feed today, saying: ‘”I’m going to go ahead and move forward with a double mastectomy.” -@GiulianaRancic’. In October, the 36-year-old initially underwent a double lumpectomy to removed cancerous growths in both breasts as well as her lymph nodes – but now she is taking extra measures after doctors failed to ‘get all the cancer out’.
Thin women do not always do well with lumpectomy. A traditional lumpectomy takes about a quarter of the breast tissue away. In smaller breasted women, a mastectomy although it represents larger scale surgery may be less deforming and usually clears the field for reconstruction.
The piece is a bit funky as it seems to blame the surgeon for not “getting all of the cancer” with the original lumpectomy surgery. Lumpectomy takes tissue out. Sometimes lumpectomy is targeted by mammograms. This is not an exact science as the cancer is not always obvious by feel. If the tissue removed does not clearly include the whole cancer, then something additional should be done. Some women choose irradiation (which makes later reconstruction very difficult) and others have a more complete operation in hopes of removing the whole tumor. This circumstance plagues even the best surgeons at times.
Breast reconstruction in thin women (should she choose this) can be difficult although small implants can occasionally be placed early with good results. I will add my hopes that Mrs Rancic has a positive outcome from her additional surgery.
John Di Saia MD
A study in the Plastic and Reconstructive Surgery Journal presents the possibility of nipple preservation not only in prophylactic mastectomy but in mastectomy for breast cancer:
Conclusions: Nipple-sparing mastectomy can be safe in properly selected patients. A subareolar biopsy can effectively identify nipple-areola complexes that may harbor cancerous cells. Ischemic complications resulting in nipple loss can be minimized, and long-term follow-up suggests that this technique deserves further investigation in properly selected patients.
This reminds me of a case in which I was involved ten years ago. Plastic surgeons tend to team up with general surgeons in the early stages of breast reconstruction. The general surgeon performs the mastectomy (breast removal) and the plastic surgeon picks up the pieces and tries to re-create the breast(s.) The call on the type of mastectomy to be performed is usually the general surgeon’s as they are generally in charge of getting the cancer out. I do try to negotiate (this is the way it feels) to preserve what we can for later use in reconstruction.
Most general surgeons take their task seriously and at times (at least in them minds of some plastic surgeons) “take too much.” While I do not blame them for this, it does make my job harder. They are trying to cure the patient. I want a wound that will heal and look as good as possible. These two ends work at odds with one another.
Well ten or so years ago, I was working with a fairly progressive general surgeon who had a patient with what was seen as early stage breast cancer. She wanted to keep her nipple after her mastectomy and this general surgeon was willing to do it. We discussed with her that this might increase the risk of the tumor coming back. She was willing to accept that risk. The surgery raised a few eyebrows at the hospital. I helped him with a skin sparing mastectomy and followed by doing a tissue-expander based breast reconstruction. She did very well.
While I think this new study helps support considering sparing the nipple in some mastectomy patients, I can’t help but wonder if many general surgeons will do it. The ugly beast called liability might just limit or prevent this.
The study only included fifty or so patients and they only followed them for three of four years, so it is not definitive. We will see how this develops over time.
John Di Saia MD
Legislation introduced in the U.S. House of Representatives would require that women be informed of their breast density when they receive their mammogram results, and that those with denser breasts be advised that they could benefit from additional screening.
Medicine is over-regulated. This bill just looks like another attempt to coerce doctors to do just one more thing, a thing that on the surface seems reasonable. Mammograms to not image denser breasts well in looking for breast cancer. So this new law would make your doctor inform you of that fact.
Say they enact a new law on breast density: How dense is dense enough? Will the law ensure that insurers pay for the additional testing recommended. The answer to question number two is usually “No.” What good does it do to know about something if you can’t do anything about it?
Mammography is a screening test. It does not and will not detect all breast cancers. The best test (my opinion) to detect breast cancer is a breast MRI. I do not know of a single insurance company that will pay for one as a screening tool.
If you want to make this law, then make it effective. Include a provision that the patient’s health insurer must pay for the test that the doctor determines useful without a long-winded approval process. Then doctors can get back to taking care of patients and not filling out forms and making phone calls gratis. Try to get your lawyer to do that.
John Di Saia MD
Cosmetic breast implants do not increase the overall risk of getting cancer, a long-term study suggests. US researchers found women with implants had a lower breast cancer risk but a higher chance of lung cancer. However, in both instances this could be due to factors such as having children and smoking rather than any effect of the implants, they say.
The BBC reported on a National Cancer Institute study of 3486 Swedish women over an average of 18 years followup. There is no increased incidence of breast cancer in women with breast implants.
John Di Saia MD
Originally posted 2006-05-12 20:20:00.
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 this FDA report is interesting, as it stands, it is 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 1 in 7 women in the US.) 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 do not 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 MD
Originally posted 2011-01-26 14:00:36.
The recall of a medical device that left particles of tungsten in women’s breasts has been classified as the most serious type of recall, one involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the Food and Drug Administration said on Wednesday. The device, the Axxent FlexiShield Mini, was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles. It is not known if tungsten is dangerous because relatively little research has been done on its long-term health effects in humans. But it shows up on mammograms and may make them difficult to read, especially troubling for women who have had breast cancer and worry about recurrences. The metal particles resemble calcium deposits, which can indicate cancer.
It is at least a bit ironic that a device intended to shield women from radiation (and future cancer risk) may potentially later make breast cancer harder to find, but that appears to be the case here. Sometimes there are negative consequences to new “breakthrough” treatments. According to this report, 27 of the affected women were treated at Hoag Memorial Hospital in Newport Beach.
John Di Saia MD