Breast Implants May Be Linked to Rare Lymphoma Cancer: FDA
Saline and silicone breast implants could be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL), according to a new warning issued by the FDA.
A breast implant medical device safety communication was issued by the FDA on January 26, indicating that there is a possible link between breast implants and the rare form of cancer that usually affects only one in every 500,000 women.
The FDA indicates that it is aware of as many as 60 cases worldwide of ALCL that developed in the breasts of women who received either silicone or saline breast implants. To have ALCL develop in the breast is even rarer, with only three per 100 million women per year diagnosed.
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Women may face a risk of Anaplastic Large Cell Lymphoma (ALCL) from certain breast implants.
Allergan Inc. and Mentor Corp., a subsidiary of Johnson & Johnson, are the manufacturers of breast implants in the United States. The FDA will require them to update label warnings on their implants to alert doctors and consumers about the reports of ALCL.
The FDA warning said that the agency believes there may be an increased risk for women with breast implants developing ALCL, but that risk is likely low. The agency is still gathering and reviewing information and hopes to have an update this Spring.
With five to 10 million breast implant recipients worldwide, the agency indicates that it cannot conclusively confirm that the implants caused the reported cases of ALCL.
In the 34 cases that have been written up in medical literature, the FDA said that the ALCL was found adjacent to the implant and contained within a fibrous capsule. The patients were usually diagnosed after complaining about implant-related problems like pain, lumps, swelling or asymmetry which occurred after the surgery had healed. The symptoms were caused by masses and fluid surrounding the breast implant, or hardening of the breast around the implant. Examinations of the area around the breasts led to the ALCL diagnoses.
In 27 of the 34 cases that were written up, the women had silicone breast implants and had them for a number of years. However there were cases involving women with saline breast implants as well.
The FDA and the American Society of Plastic Surgeons are setting up a registry for breast implant recipients who have been diagnosed with ALCL in order to get more reliable numbers and better information. The FDA is not recommending that women who have already received breast implants have them removed, nor are they calling for a breast implant recall.
A silicone breast implant recall was issued in 1992 because manufacturers had failed to provide the FDA with necessary medical data showing that the implants were safe and effective. There were concerns at the time of possible breast cancer links, but studies did not find a connection and silicone implants were returned to the market in 2006.
ALCL is not a form of breast cancer, although it can occur in the breasts, the FDA noted. It is a form of lymphoma; which affects cells related to the immune system.
Any women who have breast implants and have been diagnosed with ALCL are asked to call the FDA’s MedWatch program at www.fda.gov/medwatch/index.html.
7 Comments
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vanessaApril 11, 2018 at 6:29 am
ive been ill over 10 yeARS .. one of my implants have errupted .. I want them out now and cant afford it .. any suggestion /??
JoanneFebruary 28, 2016 at 10:52 pm
I also had ALCL (T-cell Alk negative non hodgkin lymphoma) diagnosed in December 2014. I had six rounds of chemo and had my implants removed a couple months after that. I didn't have any radiation. I underwent an autologous bone marrow transplant a few months after that to try to reduce my chances of the cancer returning.
CherylFebruary 2, 2015 at 11:01 pm
I was diagnosed with large T cell ALK negative non Hodgkin lymphoma in September 2014. I have had 6 months of aggressive chemotherapy; my implants removed just recently, and will have 4 weeks of radiation. My Dr.s believes it was due to my saline implants that I had done in in 1999. This is a very rare type of cancer and less than 60 cases have actually been reported. I would like know if anyon[Show More]I was diagnosed with large T cell ALK negative non Hodgkin lymphoma in September 2014. I have had 6 months of aggressive chemotherapy; my implants removed just recently, and will have 4 weeks of radiation. My Dr.s believes it was due to my saline implants that I had done in in 1999. This is a very rare type of cancer and less than 60 cases have actually been reported. I would like know if anyone has the same experience.
LoriAugust 23, 2011 at 2:52 am
Dear Nicki, I'm Lori and would like to know how to contact you. I would like to talk to you regarding what your adverse effects are from the Dexamethasone. I am seeing specialists too. They can't find any diagnosis for my suffering but it all started when I had the Dexamthasone treatments and has not gone away at all. I'm suffering very bad with very painful swelling and it goes right to my he[Show More]Dear Nicki, I'm Lori and would like to know how to contact you. I would like to talk to you regarding what your adverse effects are from the Dexamethasone. I am seeing specialists too. They can't find any diagnosis for my suffering but it all started when I had the Dexamthasone treatments and has not gone away at all. I'm suffering very bad with very painful swelling and it goes right to my head. I would like to find others and hopefully get a class action suit against this company before the statutes of limitations runs out. I can't work and am in fear of what this drug has done to me. I thought my symptoms would have gone away by now but I am very sick. My doctors said right after my symptoms started and I stopped the Dex treatments that it is a reaction from the drug and I took antihistimines for a month or so but they did not help me. I found out after I stopped my treatments that my bottle was one of the recalled lots. Please contact me so we can talk more about this. Lori
NickiApril 7, 2011 at 1:47 am
I am also suffering from this drug taken from 1/25 to 2/25 this year. I'm seeing specialists and just looked into attorneys. I'd like to talk with you. Please email me if you want to talk with me. I saw that a law firm in Balt. has 19 people in the North who were sickened due to Dex.
LoriFebruary 10, 2011 at 3:15 pm
I would like to be party to any class action suit any company associated with the making and selling of dexamethasone. I am suffering bad and I know it is a result of the treatments I recently had with this drug. Please contact me if you are an attorney regarding this drug Dexamethasone........
TerriFebruary 10, 2011 at 8:05 am
I had implants (solid silicone) in 2002 and now have huge lumps in my neck (above collarbone) and under arm. All my symptoms point to Hodgkins/Non Hodgkins lymphoma. Having scans/Xrays soon. I live in the UK so I guess I can't pursue a case.