Textured Breast Implants and Lymphoma
Brad Denney, MD discusses the link between textured breast implants and Lymphoma. He shares factual information for providers so they can help their patients make more informed decisions when deciding on breast implants.
Featuring:
CME Post Test Information:
Release Date: December 5, 2019
Reissue Date: November 14, 2022
Expiration Date: November 13, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no relevant financial relationships with ineligible companies to disclose.
Faculty:
Brad Denney, MD
Assistant Clinical Professor in Plastic Surgery
Dr. Denney has no relevant financial relationships with ineligible companies to disclose. There is no commercial support for this activity.
Brad Denney, MD
Dr. Brad David Denney is a native of Birmingham and graduated from Mountain Brook High School. Dr. Denney received his bachelor's degree from The University of Georgia, graduating Summa Cum Laude. He then received his medical degree from the University of Alabama School of Medicine in Birmingham.CME Post Test Information:
Release Date: December 5, 2019
Reissue Date: November 14, 2022
Expiration Date: November 13, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no relevant financial relationships with ineligible companies to disclose.
Faculty:
Brad Denney, MD
Assistant Clinical Professor in Plastic Surgery
Dr. Denney has no relevant financial relationships with ineligible companies to disclose. There is no commercial support for this activity.
Transcription:
UAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Welcome. Today we’re talking about the risk of textured breast implant associated anaplastic large cell lymphoma. My guest is Dr. Brad Denney. He’s an Assistant Professor and a double board-certified plastic surgeon at UAB Medicine. Dr. Denney, a pleasure to have you with us. Tell us a little bit about textured breast implant associated anaplastic large cell lymphoma or BIA ALCL.
Brad Denney, MD (Guest): Sure. So anaplastic large cell lymphoma or breast implant associated anaplastic large cell lymphoma otherwise known as ALCL was first reported by the FDA in 2011 as having a possible link to textured breast implants. And since then, there has been extensive research into this topic. But basically, ALCL is a specific form or T-cell lymphoma associated with patients having textured implants. Now you mentioned lymphoma, you mentioned cancer and it can be kind of scary. I will say though, that it’s a rare lymphoma and it has a risk associated anywhere from one to three thousand to one to thirty thousand risk associated with textured implants.
Now this has only occurred in textured implants and when I say textured, what that means is there are two kinds of shells that cover an implant. There’s a smooth shell and there’s a textured shell. And the reason the implant makers developed a textured shell was to combat the phenomenon known as capsular contracture. That is in any medical device whether it’s a breast implant or a pacemaker or any kind of foreign object within a human; the human body will form a shell around that foreign object and that shell is called a capsule. Well in a breast implant over time, that capsule can become very hard and firm. It can squeeze the implant and that can cause one of two things. It can either distort the look of the breast and therefore be unaesthetically pleasing and in it’s worse case scenario, it can be painful.
So, in order to combat capsular contracture; textured breast implants were developed. The thought being that the texturization of the shell and what I mean by that is the shell is literally rough. It feels like an abrasive surface. That texturization would help break up or stop the process of capsular contracture. To this date, we have found that there is some evidence that supports that an implant placed in a sub-glandular position as opposed to a submuscular position can help decrease capsular contracture, but the data is limited.
The other reason that textured implants had become popular or have been used is because texturizing the shell of an implant helps create – you can create the implant to be shaped, to be shape like a breast so, there are some plastic surgeons who think that a textured implant is because it is shaped more like a breast as opposed to round like a ball that it will give a more aesthetically pleasing breast shape. Now, the flip side of it is after the initial report that there may be a linkage between these textured implants and ALCL after extensive research, we have found that that link is true.
It's an interesting lymphoma in that it takes ten years for the lymphoma to develop from the time the implant is placed. And we think the reason of that is, is because there is friction between the textured implant and the soft tissue. And that friction basically creates inflammation and that inflammation stirs up the T-cells and then those T-cells later change into a type of lymphoma and that’s why it takes ten years to develop this ALCL.
The good news is that it’s easily treatable and with a good prognosis after treatment. The treatment is removing of that breast capsule and removing the breast implant and that alone gives a very good prognosis with most not needing chemotherapy or even radiation after that particular treatment.
Host: That was an excellent summary. Dr. Denney so, in the United States, are these being used in Europe? Are they being used? What does the FDA know about breast implant associated lymphoma? Tell us a little bit about what’s going on in other parts of the world and in this country as far as still using the textured breast implants.
Dr. Denney: Over the summer, the FDA met with leaders in the field of plastic surgery from the major governing bodies of plastic surgery to discuss this topic and to come up with guidelines and rules and regulations. And it was determined as I mentioned, that the linkage and association is real, but the risk is low. Therefore, textured implants have not been banned but there is a higher degree of awareness and education for plastic surgeons to communicate with their patients. There is a higher degree of need for plastic surgeons to communicate to their patients what textured implants provide and the associated risk of ALCL.
That being said, there is one implant that has been discontinued because of its stronger association between itself and ALCL and that is the Allergan textured implant known as BIOCELL. The recommendation is that Allergan has agreed to discontinue production of that implant but patients who have a Allergan BIOCELL implant, unless they have symptoms; they need not worry. They don’t have to go to their surgeon tomorrow and have them removed. The recommendation is to only report to your surgeon if they have particular symptoms and those symptoms are unilateral swelling and usually the number one sign or symptom of developing ALCL is swelling of the breast where the implant is in question.
Other recommendations that came out of this meeting from the FDA and leaders in the filed of plastic surgery is that plastic surgeons will have a more heightened awareness to report cases of ALCL if they diagnose them. There is a database that all plastic surgeons have access to and if they find cases of ALCL, they report these cases to the database. That allows for better research into the process for us to know more about ALCL and its characteristics.
Host: So, then based on all of that information; what should breast cancer patients considering implant reconstruction discuss with their physicians as far as benefits and risks of the different types of implants and even for women that are doing it for cosmetic reasons? What would you like them to ask their physicians and how would you like the physicians to counsel them on the different types of implants that are still available?
Dr. Denney: If patients are considering breast reconstruction with implants or cosmetic breast surgery with implants; they should ask their surgeon whom they are seeing if they used textured implants and their reasons for using textured implants. And then in response, the plastic surgeon should explain their reason for why they use textured implants but at the same time, it’s the surgeon’s responsibility to describe and go over the data on the association between textured implants and ALCL.
Host: It’s great information. Thank you so much Dr. Denney for joining us today and sharing your incredible expertise. Thank you again. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That wraps up this episode of UAB Med Cast. For more information on resources available at UAB Medicine, please visit our website at www.uabmedicine.org/physician. If you as a provider found this podcast informative and educational, please share on your social media, share with other providers and be sure not to miss all the other fascinating podcasts in the UAB library. This is Melanie Cole.
UAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Welcome. Today we’re talking about the risk of textured breast implant associated anaplastic large cell lymphoma. My guest is Dr. Brad Denney. He’s an Assistant Professor and a double board-certified plastic surgeon at UAB Medicine. Dr. Denney, a pleasure to have you with us. Tell us a little bit about textured breast implant associated anaplastic large cell lymphoma or BIA ALCL.
Brad Denney, MD (Guest): Sure. So anaplastic large cell lymphoma or breast implant associated anaplastic large cell lymphoma otherwise known as ALCL was first reported by the FDA in 2011 as having a possible link to textured breast implants. And since then, there has been extensive research into this topic. But basically, ALCL is a specific form or T-cell lymphoma associated with patients having textured implants. Now you mentioned lymphoma, you mentioned cancer and it can be kind of scary. I will say though, that it’s a rare lymphoma and it has a risk associated anywhere from one to three thousand to one to thirty thousand risk associated with textured implants.
Now this has only occurred in textured implants and when I say textured, what that means is there are two kinds of shells that cover an implant. There’s a smooth shell and there’s a textured shell. And the reason the implant makers developed a textured shell was to combat the phenomenon known as capsular contracture. That is in any medical device whether it’s a breast implant or a pacemaker or any kind of foreign object within a human; the human body will form a shell around that foreign object and that shell is called a capsule. Well in a breast implant over time, that capsule can become very hard and firm. It can squeeze the implant and that can cause one of two things. It can either distort the look of the breast and therefore be unaesthetically pleasing and in it’s worse case scenario, it can be painful.
So, in order to combat capsular contracture; textured breast implants were developed. The thought being that the texturization of the shell and what I mean by that is the shell is literally rough. It feels like an abrasive surface. That texturization would help break up or stop the process of capsular contracture. To this date, we have found that there is some evidence that supports that an implant placed in a sub-glandular position as opposed to a submuscular position can help decrease capsular contracture, but the data is limited.
The other reason that textured implants had become popular or have been used is because texturizing the shell of an implant helps create – you can create the implant to be shaped, to be shape like a breast so, there are some plastic surgeons who think that a textured implant is because it is shaped more like a breast as opposed to round like a ball that it will give a more aesthetically pleasing breast shape. Now, the flip side of it is after the initial report that there may be a linkage between these textured implants and ALCL after extensive research, we have found that that link is true.
It's an interesting lymphoma in that it takes ten years for the lymphoma to develop from the time the implant is placed. And we think the reason of that is, is because there is friction between the textured implant and the soft tissue. And that friction basically creates inflammation and that inflammation stirs up the T-cells and then those T-cells later change into a type of lymphoma and that’s why it takes ten years to develop this ALCL.
The good news is that it’s easily treatable and with a good prognosis after treatment. The treatment is removing of that breast capsule and removing the breast implant and that alone gives a very good prognosis with most not needing chemotherapy or even radiation after that particular treatment.
Host: That was an excellent summary. Dr. Denney so, in the United States, are these being used in Europe? Are they being used? What does the FDA know about breast implant associated lymphoma? Tell us a little bit about what’s going on in other parts of the world and in this country as far as still using the textured breast implants.
Dr. Denney: Over the summer, the FDA met with leaders in the field of plastic surgery from the major governing bodies of plastic surgery to discuss this topic and to come up with guidelines and rules and regulations. And it was determined as I mentioned, that the linkage and association is real, but the risk is low. Therefore, textured implants have not been banned but there is a higher degree of awareness and education for plastic surgeons to communicate with their patients. There is a higher degree of need for plastic surgeons to communicate to their patients what textured implants provide and the associated risk of ALCL.
That being said, there is one implant that has been discontinued because of its stronger association between itself and ALCL and that is the Allergan textured implant known as BIOCELL. The recommendation is that Allergan has agreed to discontinue production of that implant but patients who have a Allergan BIOCELL implant, unless they have symptoms; they need not worry. They don’t have to go to their surgeon tomorrow and have them removed. The recommendation is to only report to your surgeon if they have particular symptoms and those symptoms are unilateral swelling and usually the number one sign or symptom of developing ALCL is swelling of the breast where the implant is in question.
Other recommendations that came out of this meeting from the FDA and leaders in the filed of plastic surgery is that plastic surgeons will have a more heightened awareness to report cases of ALCL if they diagnose them. There is a database that all plastic surgeons have access to and if they find cases of ALCL, they report these cases to the database. That allows for better research into the process for us to know more about ALCL and its characteristics.
Host: So, then based on all of that information; what should breast cancer patients considering implant reconstruction discuss with their physicians as far as benefits and risks of the different types of implants and even for women that are doing it for cosmetic reasons? What would you like them to ask their physicians and how would you like the physicians to counsel them on the different types of implants that are still available?
Dr. Denney: If patients are considering breast reconstruction with implants or cosmetic breast surgery with implants; they should ask their surgeon whom they are seeing if they used textured implants and their reasons for using textured implants. And then in response, the plastic surgeon should explain their reason for why they use textured implants but at the same time, it’s the surgeon’s responsibility to describe and go over the data on the association between textured implants and ALCL.
Host: It’s great information. Thank you so much Dr. Denney for joining us today and sharing your incredible expertise. Thank you again. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That wraps up this episode of UAB Med Cast. For more information on resources available at UAB Medicine, please visit our website at www.uabmedicine.org/physician. If you as a provider found this podcast informative and educational, please share on your social media, share with other providers and be sure not to miss all the other fascinating podcasts in the UAB library. This is Melanie Cole.