Breast implants linked to anaplastic large T-cell lymphoma
By David Liu, Ph.D.
Sunday Dec 24, 2011(foodconsumer.org) -- Breast implants are certainly unnatural and may raise risk for life-threatening diseases like cancer and their complications occur often in the recipients, many study reports suggest.
If you are an avid news reader, you should have known by now that something happened in France about breast implants.
Media reports say French company Poly Implant Prothese has used sub-standard industrial grade of silicone to make breast implants that were eventually used by about 300,000 women worldwide.
The company used the low-grade silicone because it is much cheaper than the medical silicone gel. Reuters reported that medical silicone gel cost about $60 for 441 pounds while the industrial grade version cost about $10.
It is not clear though what harm the faulty breast implants would do to the recipients. But France's health authorities suggested that women who have received the breast implants of concern should get them removed by their doctors. The French government is willing to foot the bill.
The faulty silicone breast implants were also used in other countries where health authorities do not recommend removal of breast implants made by the French company. News media say that the material of concern is not used in the United States.
Are breast implants safe?
Doctors may not always tell you the truth. In many cases like this, they don't know the truth in the first place. In the case of breast implants, it does not matter the breast implants are made of saline or silicone gel, studies have suggested that they may increase risk of certain types of malignancies.
One risk that is found increased among breast implant recipients is anaplastic large T-cell lymphoma, which is a rare non-Hodgkin's lymphoma that is often diagnosed 8 to 10 years post-surgery.
Studies showed that using breast implants is certainly associated with increased risk of ALCL. The association is certain, but it is just unknon whether implants are responsible for the increased risk. But the possibility can't be excluded either.
M. Jewell and colleagues at Jewell Plastic Surgery Center in Eugene, Oregon reported a review on anaplastic large T-cell lymphoma and breast implants in the Sept 2011 issue of Plastic and Reconstructive Surgery saying " An association without evidence of causation was reported between breast implants and ALCL."
B. Kim and colleagues from RAND Health and Pardee RAND Graduate School, RAND Corporation in Boston, MA also enlisted ten experts from national specialty societies, academic department chairmen and well known researchers in the U.S. to review the issue and the panelists reportedly agreed that there is a positive association between breast implants and ALCL development.
The panelists were cited as saying in the report in the same issue of the journal that the true number of cases were under-recognized.
The association between breast implants and ALCL has drawn attention from the U.S. Food and Drug Administration. The agency posted a review on its website in January, 2011 to address the issue.
The FDA found the following:
1. There is a possible association between breast implants and ALCL.
Based on the published case studies and epidemiological research, the FDA believes that there is a possible association between breast implants and ALCL. Based on available data, the incidence of ALCL, even in breast implant patients, appears to be very low.
However, despite the low total number of reported cases, certain factors suggest the occurrence of ALCL in patients with breast implants may not be coincidence. If ALCL in women with breast implants were due only to chance, one would expect for it to occur with similar frequency in all parts of the breast. Instead, ALCL is usually located in the region immediately surrounding the breast implant. Furthermore, the vast majority of primary breast lymphomas reported in patients without breast implants are of the B-cell phenotype (Domchek, 2002). In contrast, ALCL is a T-cell lymphoma, suggesting the observation may be more than chance (Miranda, 2009).
2. At this time, it is not possible to identify a specific type of implant associated with a lower or higher risk of ALCL.
We do not have enough information to determine if a specific type of implant (silicone versus saline) or reason for implant (reconstruction versus aesthetic augmentation) is associated with a smaller or greater risk. Brody et al. (2010) noted that to date, when the implant type has been identified, ALCL has been found more frequently in association with breast implants having a textured outer shell rather than a smooth outer shell. However, most of the ALCL cases reported in breast implant patients failed to include information about the texture of the shell. Therefore the FDA cannot determine whether ALCL may be found more or less frequently in women with textured breast implants than in women with smooth breast implants.
3. There is uncertainty about the true cause of ALCL in women with breast implants.
Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. Because ALCL is so rare, even in breast implant patients, a definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established.
According to the FDA, breast implants can also cause numerous complications including breast asymmetry, breast pain, breast tissue atrophy, calcification or calcium deposits under the skin around the implant, capsular contracture, deflation or leakage of salt water solution from saline based implants, delayed would healing, hematoma, infection, inflammation or irritation, lymphedema or lymphadenopathy, necrosis, nipple/breast sensation changes, ptosis, palpability (the implant can be felt through the skin), seroma, skin rash, and wrinkling or rippling of implants among other things.
The adverse effects are the reason why many recipients of breast implants regretted that they received the surgery.
The FDA recommend that women who are considering breast implants should consider the following:
Breast implants are not lifetime devices; the longer you have your implants, the more likely it will be for you to have them removed.
The longer you have breast implants, the more likely you are to experience local complications and adverse outcomes.
The most common local complications and adverse outcomes are capsular contracture, reoperation, implant removal, and rupture or deflation of the implant. Other complications include wrinkling, asymmetry, scarring, pain, and infection at the incision site.
You should assume that you will need to have additional surgeries (reoperations).
Many of the changes to your breast following implantation may be cosmetically undesirable and irreversible.
If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, puckering, wrinkling, breast tissue loss or other undesirable cosmetic changes.
If you have breast implants, you will need to monitor your breasts for the rest of your life. If you notice any abnormal changes in your breasts, you will need to see a doctor promptly.
If you have silicone gel-filled breast implants, you will need to undergo periodic MRI examinations in order to detect ruptures of the implant that do not cause symptoms (“silent ruptures”). For early detection of silent rupture, the FDA and breast implant manufacturers recommend that women with silicone gel-filled breast implants receive MRI screenings 3 years after they receive a new implant and every 2 years after that. MRI screening for implant rupture is costly and may not be covered by your insurance.
If you have breast implants, you may have a very low but increased risk of developing a rare type of cancer called anaplastic large cell lymphoma (ALCL) in the breast tissue surrounding the implant. (ALCL is not breast cancer.) Women diagnosed with ALCL in the breast may need to be treated with surgery, chemotherapy and/or radiation therapy.
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