Rare ALCL Cancer Linked to Breast Implants

(PLEASE SEE UPDATED INFORMATION ON THIS SUBJECT IN MORE RECENT POSTS: APRIL 2018, MARCH 2019, JULY 2019)

Scientists have been investigating a rare form of cancer occurring adjacent to breast implants (not well-known breast cancer) named Anaplastic Large Cell Lymphoma (ALCL). This entity gained attention recently when the FDA released a statement. Their information can be found at www.FDA.gov/breastimplants or www.FDA.gov/MedicalDevices/Safety/AlertsandNotices/ucm24000.htm

Here is some background information. Early reports date back 25 years and a JAMA article appeared in 2008. Following this the American Society of Plastic Surgeons contracted with the Rand Corporation to do independent evaluation and this information was used by the FDA for its 2011 announcement. The FDA did not change the regulatory status or availability of breast implants.

ALCL occurs in breasts without implants at a rate of 6 women per year in the US (3 in100 million). That makes it 18/millionth the rate of common breast cancer. It also occurs more commonly elsewhere in the body (1 in one-half million). There types appear to be more aggressive, with 30% five-year survival.

With implants 34-60 cases among 5-10 million women have been described worldwide. These types appear less aggressive. No deaths have been reported in published cases. It has been found near both silicone gel and saline breast implants. It has been found in both cosmetic and reconstructive patients.

The breast implant associated ALCL presents clinically as a late seroma (fluid collection) or mass in the capsule surrounding the implant. Recommended treatment is being researched, but removal of the capsule and any mass appears to cure the condition. Mastectomy did not appear to be necessary.

The American Society of Plastic Surgeons is working with the FDA to establish a registry at the FDA to collect new & existing data and allow careful scientific evaluation of the rare condition. This will guide scientists, regulators, surgeons and patients in making informed decisions.