The FDA reported that breast implants may increase the risk of developing a form of lymphoma. Can a doctor explain whether this is with all types of implants? With any specific breast implant positioning? What's the actual risk for a woman with implants?
Breast Implants and Lymphoma
Doctor Answers 15
FDA statement on possible risk of ALCL and breast implants
Earlier today, the FDA released a safety document on a possible association between breast implants (saline and silicone) and a very rare form of lymphoma – anaplastic large cell lymphoma (ALCL). While lymphomas can appear anywhere in the body, this very rare condition can appear in the scar tissue that forms around the breast implant. Since 1989, only 34 cases of ALCL have been identified out of the estimated 10 million+ implants placed worldwide. So essentially, the chances of getting struck by lightning are more than getting this condition. In addition, my understanding is that in these rare published reports, where the implant and surrounding scar tissue was removed - the condition resolved.
The FDA states that this condition is extremely rare and is clearly not breast cancer, but is working with the American Society of Plastic Surgeons (ASPS) to study this matter further. At this time both the FDA and the ASPS remain confident that breast implants are safe and effective. Breast implants do NOT cause breast cancer.
Remember, breast implants are the most studied device in the history of medicine. If you have implants, continue your routine monthly breast self exams, mammograms/breast cancer screen when needed. If you feel any changes to your breasts, visit with your physician/plastic surgeon. For more information on breast implants and current info on this specific topic, please visit the ASPS website (link below) or visit with a board certified ASPS member surgeon.
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The FDA Got it WRONG: Smooth-Walled Breast Implants (Both Silicone and Saline) Do Not Pose a Cancer or Lymphoma Risk
As many surgeons have pointed out, the chances of getting Lymphoma as a result of breast implants is extremely low.
The more important issue, I believe, is what the FDA did not point out in their January 26, 2011 notification. The FDA has seemingly ignored reported data indicating that in all cases where breast implant information was available in these rare cases of lymphoma, that none were identified in "smooth-shell" breast implants.
Dr. Garry Brody, likely the world's top expert on the topic, reported in March 2010 that in the 25 out of 34 cases reported world-wide of Lymphoma in breast implant patients, that every patient had a "textured-shell" type of breast implant.
Dr. Brody confirmed to me in April 2010 that he was not aware of any cases associated with smooth-walled implants. Lymphomas have consistently been identified only in symptomatic patients who have swelling or pain in their breasts.
I use exclusively "smooth-walled" implants (both Silicone Gel and Saline) for breast augmentation in my Denver, Colorado practice and I feel that my patients are statistically not susceptible to Lymphomas. Nonetheless, I encourage all patients to be evaluated if there is a change in the breast that is concerning.
I have written a recent blog post on this topic where I go into more detail on this issue -- see the link below.
Hope this helps,
Nick Slenkovich MD, FACS
Breast implants and lymphoma
The study showing a link between breast implants and a specialized type of lymphoma notes that some cases may have been duplicated, not reported correctly, or (most worrisome) missed altogether. Does this mean that many women were counted more than once? Or forgotten altogether from the study?
Also the numerator, the total number of breast implants performed is in the millions, so is this number significant?
Further studies and statistical analysis will hopefully shed some light on this potential relationship.
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ALCL and Breast Implants-What is the Risk of Lymphoma?
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 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.” The FDA has stated, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”
- According to the FDA, the incidence of ALCL of the breast is 3 per 100,000,000 women
- According to the FDA 60 cases of ALCL of the breast have been reported for the 5-10 million women with breast implants
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. s of January 26, 2011, approximately 60 cases of breast implant-associated ALCL have been identified by the FDA. This number is based upon 34 case reports in the medical literature and additional cases reported directly to the FDA. Tally case reports in the medical literature and relying on adverse event reporting to the FDA are unreliable methods of determining the actual incidence of a disease or condition, and as such, we really don't know how many women with breast implants have developed ALCL and therefore cannot reliably estimate risk. Furthermore, even if we could accurately know how many have implants and how many of those women with developed ALCL, we still would not be able to accurately assess risk. That's because we would also need to know how long each of those women had their implants in. The reason time is important here is because ALCL seems to develop years after breast implants are placed-8 years on average from implant placement to ALCL diagnosis for the cases reported in the medical literature-so counting women who had implants placed last year could be misleading.
Furthermore, because the information about ALCL was not reported in a uniform way, we do not now for certain whether, as you asked, particular implants or implant positions are more likely to lead to ALCL. Furthermore, at this time, we have only limited understanding of breast implant-associated ALCL. For example, in the medical literature, only 19 of the 34 reported cases include information about ALCL recurrence or the development of systemic lymphoma. Of these, 14 patients remained free of ALCL during the follow-up period, however, the average reported follow-up period was only one year. The FDA presently recommends that if a woman develops breast implant-associated ALCL, her doctors should “develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.” Reported cases of ALCL have been treated with one or more of the following: surgery, radiation and chemotherapy. According to published information on the FDA website, “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.”
The bottom line: An association between breast implants and ALCL has been identified and we are in the process of learning more about this malignancy.
Latest FDA data on ALCL in patients with breast implants.
The FDA report of January 26, 2011 states that ALCL can occur anywhere in the body. According to the SEER (Surveillance, Epidemiology, and End Results) Program of the National Cancer Institute, an estimated 1 in 500,000 women per year in the US is diagnosed with ALCL. ALCL of the breast is even more rare; approximately 3 in 100 million women per year in the US are diagnosed with ALCL of the breast. The scientific literature from January 1997 through May 2010 showed 34 cases of ALCL in women with breast implants, in up to an estimated 10 million women with breast implants, which equates to 1 case per 294,118 women (over 13.3 years), or 0.00033%.
Data from the CDC regarding lightning-related deaths show an average annual of 107 deaths over the period from 1968 and 1985, for a rate of 6.1 per 10 million, equal to 1 death in 1.6 million, or 0.00006%.
Although the risk of developing ALCL in women with breast implants is actually 5.5 times greater than the likelihood of dying from a lightning strike, both are EXCEEDINGLY RARE!
ALCL is lymphoma, NOT breast cancer, and some researchers have suggested that breast implant-associated ALCL may represent a new clinical entity with less aggressive behavior (Li, 2010; Miranda et al, 2009; Thompson et al, 2010). Because of the extremely small number of cases and short median duration of follow-up, the FDA states that it is premature to draw conclusions regarding prognosis of ALCL in women with breast implants. The FDA also states that because the risk of ALCL appears very small, the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.
The FDA further states that "There is no need for women with breast implants to change their routine medical care and follow-up."
Risk of ALCL with Implants is EXTREMELY LOW
My colleagues have done a great job giving you the relevant numbers and percentages... I would add that it does seem that the risk was highest when textured implants were used, and most plastic surgeons no longer use these for breast enhancement.
FDA and reports of Lymphoma in Breast implant Patients
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.
Lymphoma study NOT linked to smooth walled breast implants.
Of 34 women with implants and lymphoma (out of 5 to 10 million women with implants). the exact implant used was identified in 25 women. Of these 25, 23 women had implants with a particular textured surface of the type manufactured by Allergan, Inc. The other two of the 25 had polyurethane implants which are no longer used. (This study was presented by Dr. Garry Brody at the 2010 meeting of the American Association of Plastic Surgeons.)
In other words, none of the identified implants were smooth walled (saline or silicone). The majority of women in the United States have smooth walled implants. So for this large group, these findings do not seem to apply.
Mentor, Inc. also makes textured implants, but the surface is entirely different and created by a different manufacturing process.
For women with Allergan textured implants, I would say the possible risk, even if real, is so tiny (about 3 per million) that you should not worry about it. As an Allergan spokeswoman said (quoted in The New York Times): "A woman is more likely to be struck by lightening than get this condition."
Breasts Implants Risk of Lymphoma
Informing the "world" of a low incidence of this relationship (30 cases in over 10 million implantations = 0.000003% occurrence rate) causes increased discussions and increased removal of implants. But science will determine if this very slight risk is an issue. Stay tuned. From MIAMI Dr. Darryl J. Blinski
Possible association breast implants and lymphoma
There will be many questions about this report of collaboration with plastic surgeons and the FDA concerning reported anaplastic large cell lymphoma in 34 patients with breast implants. The cases have been reported since 1989, a period in which 10 million breast implant procedures have been performed. At this time we know that the lymphoma is very rare and few plastic surgeons have even heard of the condition or risk since the release yesterday. It is not breast cancer and implants do not affect breast cancer risk. You can go to the American Society of Plastic Surgery link and more information is available on the home page.