In a recent publication, the FDA indicated that there is a small risk between breast implants and a rare form of blood cancer. The type of cancer is called anaplastic large cell lymphoma (ALCL) which is a form of non-Hodgkins lymphoma, a cancer of the T-cell lymphoctyes cells in the blood.
The most important aspect of this recent FDA announcement is relating to the personal risk to each patient who has undergone a breast augmentation. Fortunately, the risk is very small. Only 50 cases have been reported (some may be duplicates) in the estimated 5-10 million breast augmentations that have been employed worldwide. That puts an individuals risk at 0.0012-0.0006 percent. Keep in mind that 1 in every 7 women will be diagnosed with breast cancer alone. That is a 14% chance that can be as high as 50% in certain women with higher genetic risk factors or positive family history.
This relationship has been seen with both types of implant textures, smooth and textured, but more commonly in the textured type. Fortunately, this type is no longer on the US market and had been infrequently used in the United States. Most implants in the US are smooth, round saline or silicone implants.
No true association has been established between breast implants and lymphoma through multiple studies.
The potential association of breast implants and lymphoma has been evaluated in several studies with long term follow up, and the published epidemiological evidence does not support an increased risk of non-Hodgkin’s lymphoma in patients with breast implants:
- An epidemiological study reviewed evidence from five long term studies of 43,000 women with breast implants and followed for up to 37 years and noted no difference in the incidence ratio of non-Hodgkin’s lymphoma in implant patients (Lipworth, March 2009).
- A Scandinavian cancer incidence study evaluated 6,222 women with breast implants including 3,336 women with 15 or more years of follow-up and 827 with 25 or more years of follow up and found no excess of lymphoma in subjects with implants (Lipworth, Jan 2009).
- A large, controlled Canadian cancer study followed 24,558 breast augmentation patients and 15,893 women who received other cosmetic surgeries and found a similar incidence of non-Hodgkin’s lymphoma after over 600,000 person years of follow-up (Brisson, 2006).
- A Dutch study concluded there may be an association of ALCL and breast implants but suffered methodologically (Evens 2008) by having controls that were not comparable to the cases (ALCL) since the controls were lymphomas other than ALCL (de Jong, 2008). They reported that 6 of 11 primary breast ALK1-negative ALCLs had no history of silicone breast implantation, while 5 did, and 1 patient developed ALCL one year after cosmetic implantation. In addition, the author’s analysis was based on 5 saline-filled breast implants—including 2 initially observed or “trigger” cases of women with both ALCL and breast implants over a 17 year period.
- The results of the Allergan Breast implant sponsored clinical trials have been reported at the ASPS meeting in Toronto (October 2010). For all 89,382 patients, with 204,681 patient years of follow-up, the number of lymphomas observed divided by those expected (26/43) yields a standardized incidence ratio (SIR) of 0.6.
Several studies have shown that women with breast implants have an overall lower risk of breast cancer than the general population. (Deapen DM, 1997 & 2007) ALCL comprises a very small percentage of all lymphomas and is an extremely rare pathological entity (0.2 per 100,000 person years) (SEER 2008).
With the extremely rare incidence of ACLC, there is limited ability to make any formal conclusions relating to lymphoma and breast implants. Active, ongoing research is underway to understand the relationships relating to breast implants and the development of lymphoma, but little evidence currently suggests any causal relationship.
Some of the unlikely events that might happen in ones life that are MORE likely than getting ALCL cancer relating to breast implants are:
0.054% – chance of dying from a car accident
0.0012 % – chance of dying from an accidental drowning
0.0012 % – chance of dying from a fire or smoke inhalation
0.0012-0.0006% – ALCL from breast implants
12.2% – chance of breast cancer with or without implants (1 in 8 women)
The chance of breast cancer appears to be 10,000 times more likely with the current information we presently have available.
In conclusion, although it has come to light that there have been a number of patients who developed ALCL in the setting of having a previous breast augmentation, no causal or linked relationship has been demonstrated. The risks are extremely low and are not currently linked to the presence of breast implants. Both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery has not recommended a change in current practice or in how breast augmentation procedures are performed.11:13 PM