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March 2017 FDA Report: Breast Implants Linked To Lymphoma Blood Cancer

April 3, 2017 By Law Offices of Thomas J. Lamb, P.A.

You may have heard about the March 2017 FDA update report concerning a little-known and rare type of lymphoma, or blood cancer, which has been developing in some women who have had breast implant procedures done for augmentation or reconstruction purposes.

From this March 21, 2017 article, “9 Deaths Are Linked to Rare Cancer From Breast Implants”, published by The New York Times (NYT), we get some basic information regarding this still-emerging health problem:

About 290,000 women in the United States had implants for breast enlargement in 2016, and 109,000 received them for reconstruction after breast cancer, according to the American Society of Plastic Surgeons.

In many cases when the lymphoma occurs, just removing the implant and the tissue around it eliminates the disease. But some women may need chemotherapy and radiation.

In more detail, the FDA updated its “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)” information page in March 2017.

The most notable new facts are found in the Medical Device Reports part of this FDA breast implants – lymphoma page, specifically the most-current figures on the number of BIA-ALCL cases:

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.

The earlier referenced March 21 NYT news story also provides some contextual information which seems to help us understand the timing of this recent FDA announcement about breast implants and lymphoma:

A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network.”

Of course we will continue to monitor the medical literature and regulatory realm for further developments concerning breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

[Read this article in full at original source]

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Filed Under: Unsafe Medical Devices Tagged With: anaplastic large cell lymphoma, blood cancer, breast implant-associated anaplastic large cell lymphoma, breast implants, non-hodgkin lymphoma, smooth breast implants, T-cell lymphoma, textured breast implants

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