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Home Page >> Potential Lawsuit >> Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)


Washington, DC: The US Food and Drug Administration (FDA) has issued an update in line with the World Health Association, which designates breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.

The FDA states that currently, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

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.

BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma (a pocket of clear fluid that can occur following surgery). The agency notes that the exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.

In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma.

In 2016, The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants. Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) have published information to help physicians understand the disease and provide diagnosis and treatment.

Regulatory bodies outside the United States have issued communications on BIA-ALCL.

The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.

The FDA also notes in its review of the available medical literature, that all of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.



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Last updated on Mar-21-17

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READER COMMENTS

I was diagnosis Aug 18th 2015 with Anaplastic large cell lymphoma alcl neg I had textured implants had them removed due to painful swollen implant it was ruptured with a lot of discomfort and compilations. Plastic Surgeon removed them but put new implants in when she found the fluid (seroma) I had pain ever since they removed them on Nov 28th 2016. The Doctor stated there was no anaplastic capsule on my left breast . I went to Cleveland Clinic July 22nd 2016 they done four mri,s two ultra sounds on my breast said I still have the capsule in me. When I was told I had it and they where going to watch me for the next five yrs. I still have pain but they found a spot on right side now I had a mri done this March 2017 they wanted to do a biopsy but I put that on hold. I seen doctor at U of M on March 22nd 2017 he basically blew me off. I was just wondering if I have a case sometime down the road about this pain and suffering had games I been threw the past two yrs. thank you.

Posted by susan mrowiec on

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