Breast Implants and Cancer: The 0.000003% Risk of ALCL

mellieb on 27 Jan 2011 at 1:45pm

Yesterday the FDA announced a link between breast implants and a rare type of cancer called anaplastic large cell lymphoma. The cancer is located in the scar tissue surrounding the implant, but not the breast tissue itself.

While the announcement set the media world afire, the overall risk of getting this type of cancer is quite low. The FDA reports: "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."

Doctors in the RealSelf community have suggested a few ways to quantify this risk:

  • Dr. C. Bob Basu, a Houston-based plastic surgeon notes, “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.”
  •  William A. Wallace, an MD from Jacksonville states, “I can't say that there isn't a correlation, but it would appear that this is a very VERY rare phenomenon. In mathematical terms: 34 women with ALCL out of 10,000,000 women with breast implants. This equates to a 0.000003% of developing ALCL as a result of having breast implants (if there is an association).”

This study is likely to be closely looked at in the coming months, and the FDA is working with the American Society of Plastic Surgeons to track the number of women with breast implants who have this rare form of cancer. While this may give some women pause, few anticipate the demand in breast enhancement surgery to change in the near term.

Comments (2)

Dr. Scott E. Kasden
The FDA this week announced that breast implants may be associated with a rare form of (non-Hodgkin’s) lymphoma. This specific lymphoma is called anaplastic large-cell lymphoma (ALCL).

The important points to know:

Total cases: 34
Silicone gel filled: 27
Saline filled: 7
Possibly another two dozen cases worldwide (no info on that yet).
No word yet on location of implants (under vs. over the muscle).
Millions of breast implants placed !


FDA feels link needs to be confirmed, but women with implants may have a very small but increased risk of ALCL.

FDA feels that implants are safe and effective when used as labeled (this may change over time).

What you need to know:

Symptoms of this rare cancer include enlarging, deforming of implanted breast, possibly pain. This may be similar in presentation to a capsular contracture.

The cancer usually develops years after implantation.
The cancer develops in or around the capsule, giving weight to a causality or link.
The tumor is usually associated with a new fluid collection.
Cures have been reported with implant removal and capsulectomy alone!

What you need to do if you have implants:

Don’t panic.
There is NO recommendation to remove the implants at this time if they are not causing problems
Contact your plastic surgeon.
No need to have the implants removed.
You should be aware that some sort of registry may be started in the near future to help track you and your health.
If you note symptoms, notify your plastic surgeon immediately, and again don’t panic.

More to follow as news breaks
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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.
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