Are Textured Breast Implants Safe? Canada and France Take Steps to Ban Allergan Biocell Implants, Citing BIA-ALCL Risk
Update: on July 24, 2019, Allergan issued a worldwide voluntary recall of Biocell textured breast implants at the request of the FDA. This means that Biocell implants may no longer be sold or placed in patients during breast augmentation or reconstruction. Patients who previously received Biocell implants and who are not experiencing symptoms are NOT being advised to have their implants removed. Dr. Pancholi’s patients: please call us at 702-363-0240 if you have any questions.
Textured breast implants from Allergan are under fire from several national health boards due to increasing evidence that their texturing methods are linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This is a rare form of lymphoma found in about 700 women worldwide.
While BIA-ALCL is highly curable and quite rare, the association with a particular type of textured breast implant is strong and concerning.
HealthCanada is considering suspending Allergan’s license for Biocell implants
The latest move was made by Health Canada, which on April 4th announced its intent to suspend Allergan’s license to distribute its Biocell textured breast implants in Canada. Ongoing, large-scale safety reviews have indicated a strong association between the Biocell texturing process and BIA-ALCL: of 28 confirmed BIA-ALCL cases in Canada, 24 of those patients had Allergan Biocell textured implants. HealthCanada gave Allergan 15 days to respond to its action; the company has done so, and Allergan’s response is now under review.
Decisions by public health authorities to ban a medical device or suspend a manufacturer’s license are not made lightly. As a physician, I take their actions seriously.
France’s ANSM has banned Allergan Biocell implants and several others
That same week, the French National Agency of Medicines and Health Products (ANSM) took an even more drastic measure, withdrawing Allergan Biocell implants, as well as “macrotextured” and polyurethane implants from several European manufacturers. In a press release, the ANSM made the following statement (translated from French):
“the ANSM considers that the more the implant is textured and rough, the greater the risk of occurrence of BIA-ALCL….Thus, the ANSM has decided, as a precautionary measure, to withdraw from the market some macrotextured implants of texture equivalent to the Allergan Biocell envelope and polyurethane in order to reduce the exposure of women to the risk of BIA-ALCL, which remains a rare but serious risk.”
What does the FDA have to say?
In March, the FDA’s General and Plastic Surgery Devices Panel held a special meeting on breast implant safety, with particular attention to the issues of BIA-ALCL, as well as the recent increase in reports of varied symptoms referred to by some as “breast implant illness.”
Following that meeting, the FDA recommended improving methods of gathering data on breast implants and BIA-ALCL. So far, however, the FDA has not taken any action to suspend the sale of Biocell or any other implants, only stating that they will keep the public informed of any planned action based on emerging scientific evidence.
What do I have to say as a cosmetic surgeon?
Decisions by public health authorities to ban a medical device or suspend a manufacturer’s license are not made lightly. As a surgeon, I take their actions seriously. And, while the overall risk of developing BIA-ALCL remains very low even with Biocell implants, I choose not to use these implants in my practice. In fact, I have not used them for some time, as research suggesting a link between the Biocell texturing method and BIA-ALCL was first published several years ago.
For the majority of patients, I use smooth implants; they provide beautiful results and are offered in a wide range of sizes and profiles. In cases where a patient wants textured implants or I believe they will provide the best result, I use textured implants that have been shown to have the lowest risk, or other alternatives to textured implants altogether.
I have followed and presented on BIA-ALCL to surgeons locally, nationally, and internationally over the past five years and continue to follow this topic closely. As a cosmetic surgeon, I always want to provide my patients with the most accurate information about the safety of any procedure, including breast augmentation. If you have any questions, I welcome you to contact my office at 702-363-0240.
