This news story broke last night (January 27, 2011) and I wanted to get your thoughts. http://healthland.time.com/2011/01/26/fda-breast-implants-may-be-linked-to-a-rare-cancer
FDA Says Possible Link Between Implants and ALCL Cancer - What's Your View?
Doctor Answers 13
FDA and reports of Lymphoma in patients with breast implants
I am puzzled and I do not understand why this would be limited to breast implants only.The data is compelling in that the localized nature of the ALCL, when it occurs, is very suspicious for causation. However, the incidence is extremely low and the likelihood of any one surgeon seeing more than a single case is very rare making this a very difficult problem to study. The FDA report will now make us more aware fo the condition and to be on the surveillance for this entity.
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Link Between Implants and ALCL Cancer-Perspective on Risk
The FDA this past week has alerted the general population of a POTENTIAL risk between breast implants and a rare form of Lymphoma. The plastic surgery community brought this information to the FDA several years ago in an attempt to keep them informed of our current research into the effects of breast implants in general. As has been reported, the world has been scoured for cases of this extremely rare form of Lymphoma and only a handful of cases have been found. Because the numbers are so small it is extremely difficult to determine the epidemiology surrounding the disease and produce any meaningful conclusions. We are doing nothing more than sharing some observations of what is known without saying that the two are actually related. These few cases have been described with textured surface implants which are, by far the least used type of implant in the United States. The current state of implant manufacture is such that the shell used to contain the contents of the implant is far superior to the implants from years ago and the most widely used implants in the United States are smooth walled implants that have not been associated with the disease. Over the last two decades there have been over a dozen comprehensive studies performed looking at the possible links between breast implants and systemic diseases and none have been found! This fact should be very comforting to both the general public and plastic surgeons alike.
To further put into perspective the concept of risk a few facts will be of help. First, the risk of a women developing ALCL in the United States is about 1 in 500,000 if, in fact there is a connection between breast implants and ALCL that risk, based on 3 cases in 1 million women, would increase to 1 in 333,333 women. It is a well established fact that approximately 1 in 8 women will develop breast cancer in the United States and that that number is irregardless of the fact of whether they have breast implants or not, that is, the risk is the same for women with implants as those without implants. The second thing that is sometimes difficult for people to get a perspective of is what these numbers really mean. Very few people, save epidemiologist who deal with these numbers every day, can really get a feel for the difference in risk between 1 in 500,000 and 1 in 333,000. One way to look at this is to compare it to other risks so I am going to add some statistics here that I hope will help people do this.
Cause of Death Lifetime Odds
Heart Disease 1 in 5
Cancer 1 in 7
Car Accident 1 in 100
Electrocution 1 in 5,000
Air Travel 1 in 20,000
Lightening 1 in 83,930
Hit by Asteroid from Space 1 in 500,000
We are all concerned for the safety of our patients and always err on the side of "Do No Harm" but, we also have an obligation to use common sense and reason in making our decisions.
I hope this helps in providing some small insight on perspective.
Possible Link Between A Certain Type of Breast Implant and A Rare Form of Lymphoma
As has been well stated, the exact link between breast implants and this very rare form of lymphoma is not completely clear. Even though the incidence of its occurrence is incredibly low in the total breast implant population (30 or cases in 5 to 10 million women or roughly a 0.000005% risk), its development next to a breast implant may be more than just coincidental given that the occurrence of this type of lymphoma in the breast is known to be in the range of about 3 cases per 100 million women in general. That being said, it is my understanding that these findings refer largely to a specific textured breast implant from one manufacturer which were made with one processing technique. There may be no association at all with the vast majority of breast implants that have been implanted, specifically smooth-walled breast implants. We shall have to await further findings and study clarifications. For now, the FDA is not remotely suggesting that breast implants should be removed or not be implanted for cosmetic or reconstructive breast needs.
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ALCL and Breast Implant Safety - We Still Have a Lot to Learn
The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. While ALCL is not breast cancer, it is a malignancy. Furthermore, although a conclusive causal relationship has not yet been established, it is presently thought that breast implants can play a role in the development of ALCL; the number of identified cases far exceeds the number of expected cases (3 cases of ALCL are expected per 100,000,000 women without implants). While the FDA continues to allow the sale and use of approved breast implants, the FDA has stated, “additional data is needed to fully understand the possible relationship between ALCL and breast implants.” At the time of this writing, the FDA believes, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”
The medical community is in the process of gathering more information about breast implant- associated ALCL so that we can better understand this condition and the potential risk breast implants pose. Women considering breast implants should inform themselves about ALCL and weigh the risks, the uncertainty, and the potential benefits of breast implants for themselves.
According to the FDA report, as of January 26, 2011, approximately 60 cases of breast implant-associated ALCL had been identified by the agency. This number is based upon 34 case reports in the medical literature and additional cases reported directly to the FDA. Case reports in the medical literature and adverse event reporting to the FDA are know to be unreliable methods of determining the true or actual incidence of a disease or condition. The FDA believes that only 1-10% of adverse events are actually reported to the agency, so it would not be surprising to find that with time, the actual number of cases is greater than what we know so far.
If you are considering breast implants, it is important to understand that looking at risk from the standpoint of “how many women with breast implants have developed ALCL” (i.e., ALCL cases per total number of women who have had breast augmentation) does not tell the whole story about a woman’s real risk. Since the actual number of women with breast implants is unknown—the FDA states that there are between 5 and 10 million women with breast implants worldwide—any estimation of risk based on 10 million women would immediately double if the number of women with breast implants were, in fact, 5 million. Furthermore, since ALCL appears to develop many years after breast implants are placed (the average latency, or time to development of ALCL in the reported cases was 8 years) <i>and</i> since many women only recently underwent breast augmentation surgery (296,203 breast augmentations in 2010 according to the ASPS), looking at the incidence of ALCL in relation to the total number of women who have had breast implants placed may be misleading. This is because hundreds of thousands, or possibly millions, of women who only relatively recently underwent breast augmentation and thus would not yet be at significant risk for developing ALCL—they are, so to speak, still in the latency or “incubation” period—would be counted in a statistics that measure "how many women with breast implants develop ALCL". In other words, the inclusion of these women who recently underwent breast augmentation in the calculation effectively “dilutes” the ratio and thus dilutes the appearance of risk. A more accurate way to represent the incidence of a condition with a long latency period would be to express the number of cases in terms of “patient exposure time” (which is like looking at "man-hours worked" rather than the number of workers who did work).
According to the FDA:
- Women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.
- Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.
- Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.
- Women who have breast implants should monitor their breast implants and contact their doctors promptly if they notice pain, swelling or any changes in or around their breast implants. There is no reason to contact their doctors if they have no symptoms.
- If a woman is considering breast implant surgery, she should discuss the risks and benefits of the procedure with her doctor.
The FDA is looking at a possible link of implants to anaplastic large cell lymphoma.
The plastic surgery profession has, continues, and always will look for possible connections between breast implants and other illnesses. ALCL is a very rare cancer. I've never actually known a patient or anyone else to have it. The liklihood of any woman with implants contracting it is extremely remote. Because it is so rare, it will take some time to establish any link between the implants and the condition. Remember that millions of women for decades have chosen to have implants and there have been no links to any systemic illnesses. Don't panic.
Breast Implants and Lymphoma
ALCL, or Anaplastic Large Cell Lymphoma, is an extremely rare form of lymphoma. Per the FDA statement, there are 34 published cases of ALCL in women with breast implants. This is a very very small number compared with the millions of women with implants. Of the 34 women with ALCL, 24 have silicone implants.
From the FDA report: "If you have breast implants, there is no need to change your routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants."
In short, more research has to be done to see if there is a direct link with implants and ALCL. This publication by the FDA just points to a statistically higher number of women with breast implants and ALCL as opposed to women with ALCL who do not have implants. It is not saying that the implants are causing ALCL in these women. This is the point of the ongoing investigation.
Hope that helps!
Dr. Babak Dadvand
This is an incredibly rare cancer - a form of non-Hodgkins's lymphoma. It's not breast cancer. Somewhere between 30 and 60 cases have been reported in the entire world in patients that also have breast implants. It's too early to know the details of any linkage. The patients had implants for both reconstructive and cosmetic purposes, some silicone, some saline.
Here's the bottom line: don't panic. Do your own breast self-exams. If you have a lump or swelling in the breast that is new, get it checked out. Have mammograms and breast ultrasound or MRI, as recommended by your plastic surgeon. Really, it's way more important to be looking out for breast cancer (odds around 1 in 8 ), rather than this rare bird (odds less than 1 per million).
Breast Implants and Cancer
I've read the Wall Street Journal report, not the original study, but spokespersons from the FDA and Allergan and Mentor (implant manufacturers) all agreed that while the numbers reach statistical significance, for any one woman, the chance of getting ALCL is quite rare. They did NOT recommend implant removal or even additional breast exams or other diagnostic studies. One representative from Allergan said the chance is less than the possibility of a woman being struck by lightning. My recommendation for my own patients will be to do nothing, and essentially disregard this finding until more data and analysis is available (watchful waiting). So often in medicine, results of a single study are publicized and change the way we do things, then further studies reverse the initial findings.
Breast Implants and ALCL
It is too soon to know whether a link truly exists between ALCL and breast implants.
The FDA has identified about 40 cases while over 10 million women have had implants, so no link has yet been shown.
At this time, the FDA has informed the public and plastic surgery organizations of this possible association, and is asking plastic surgeons to report any suspected cases.