In Canada, Health Canada had taken action in advance of this decision by Allergan when they announced the suspension of Allergan’s license for its BIOCELL breast implants on May 28, 2019.
The primary reason for this suspension and recall has been a recognized association between a rare type of lymphoma and textured surface medical devices. We initially wrote about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in our blog post of December 12, 2018.
It is important to know that to date, due to the low risk of developing BIA-ALCL, there has been no recommendation from regulatory agencies including Health Canada and the FDA to remove or replace textured breast implants or tissue expanders in women who are asymptomatic and have a normal examination.
I would like to provide some background and share some information regarding these recent events. In Canada, most breast implants and tissue expanders have been made and distributed by two companies (Allergan and Mentor). Both companies make implants and expanders that have one of two surfaces: smooth and textured.
Why might you have a textured surface breast implant?
There are several advantages to a textured surface implant. When using a shaped (teardrop, anatomic) implant or expander, the texturing assists in holding the implant in position so that it does not rotate. In fact, all shaped implants are textured. In the past, texturing has also been felt to decrease the incidence of some of the more common complications associated with breast implants including hardening (capsular contracture) and implants shifting out of position (malposition).
The actual cause of BIA-ALCL remains unclear but one of the most accepted theories is that bacteria may find their way into the crevices or spaces within the textured surface and stimulate an inflammatory response that in a small number of patients may eventually lead to lymphoma.
What do we suggest for our patients?
Late in 2018, our office began a process of trying to contact all of our patients with textured surface breast implants to notify them of this new information, explain what patients should look out for and to suggest that they contact our office to come for a follow-up visit that would include a discussion of patient options. This approach has been helpful in allowing us to speak to and assess many of our previous patients dating back to 2002.
If you are a patient of Dr. Brown and you have not received an email from us, it may be because you have smooth surfaced implants or it may be that we were unable to find updated contact information for you.
We encourage all of our patients to contact the office so that we can confirm for you the type of implant that you have. If you have a textured surface implant we would like to assist you in arranging a follow-up visit or if not possible for you to attend in person, then it will give us an opportunity to provide you with necessary information and to answer your questions. Additionally, all women with breast implants, regardless of the type, benefit from ongoing follow-up of their medical devices and we hope that you will continue to come for complimentary annual or biannual assessments at our office.
Please contact us with any questions or to arrange an appointment.
Dr. Mitchell Brown
Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer