Allergan has announced there will be a voluntary recall of all of their Biocell textured breast implants and expanders on Wednesday, July, 24, 2019. This was a joint decision between Allergan and the FDA. The primary concern has been an increased association with Breast Implant-Associated ALCL. This was followed by an FDA announcement aimed at patients who may have the implants and how they should proceed.
“Recall” Causes Patient Confusion
Many people associate the term “recall” with the car industry; however this recall is not totally analogous. This Biocell recall is removing new sales and surgical usage of Biocell implants, but not recalling currently implanted Biocell devices. The FDA statement clearly states that the agency does not recommend asymptomatic women with Biocell implants have them replaced.
On this No Spin Live exclusive, board certified plastic surgeons and breast augmentation experts Dr. William P. Adams Jr. of Dallas and Dr. Jason Pozner of Boca Raton discuss the important news and help patients with breast implants understand the issue.
Collaborative Decision Between Allergan and the FDA
Much has been learned in the past 10 years about BIA-ALCL that was virtually unknown prior to 2010. The exclusive association with textured breast implants became evident as data was collected. The higher incidence with Grade 3/4 or “macro-textured” implants has been established. Epidemiology and case cluster has also focused one of the main pathogenic pathways to be chronic inflammation by bacteria with exponentially higher numbers of bacteria on the more heavily textured (“macrotextured”) implants.
In the US the only macrotextured breast implant is Allergan’s Biocell. It is also known now that different textured implant carry different risk of BIA-ALCL. Biocell 1:3000, Siltex 1: 80,000, True-texture 1:100,000. The FDA Maude Database although limited due to a large amount of unconfirmed or incomplete data as well as possibility of duplicate data had demonstrated a 6x higher risk for BIA-ALCL with Biocell implants.
What About Smooth Implants
There has been some confusion about smooth implants and BIA-ALCL. This is particular interest to the United States where 95% of implants used are smooth vs. internationally where it is 95% textured. To date there has not been a confirmed documented pure smooth only case of BIA-ALCL. The FDA has reported they have 19 cases of smooth implants with BIA-ALCL; however, in none of these cases is this a confirm pure smooth only case. At the time of diagnosis the 19 FDA cases had a smooth implant, but also had a textured implants or multiple textured implants previously, or the implant history is unknown. It is also important to understand that the Global Plastic Surgery Community is extremely aware of BIA-ALCL and in no Global registry or database nor in the US Profile Registry or database, as well as any case report or publication is the a confirmed pure only smooth case. You may wonder why this would be? The science has shown that it is a function of bacterial load and with a smooth implant the sustained bacterial load is exponentially lower than textured devices.
What Should Patients Do Who Have Biocell Textured Implants?
“The FDA has reiterated that they do not recommend that an asymptomatic patient with a Biocell implant have the implant removed,” explains Dr. Pozner. “Asymptomatic” is the operative word here, as patients who do have any issues or changes in their breasts absolutely should go see their doctor.
“First of all, if you have implants, go look at your card and see what implants you have,” begins Dr. Pozner. “If you don’t have your card, call the doctor that operated on you and find out what implants you have. If you have a smooth-walled implant from any of the manufacturers, whether it’s Allergan, Mentor, Sientra, etc., don’t worry about it! Your risk of ALCL is virtually 0 with a smooth-walled device.”
“Secondly, if you have a non-Allergan textured device, whether it’s Mentor, Sientra, or other textured implants, I would say don’t worry about it because your risk of ALCL with a non-Allergan textured device again is so low, just come in for a follow-up.”
The majority > 80% of cases present with late seroma/ fluid around the implant causing an enlargement of the breast by 1-2 cup sizes. The vast majority of late seromas are not BIA-ALCL but a seroma of infectious origin. Any breast implant patient should be aware to see their board certified plastic surgeon if they experience any of the following symptoms:
- Enlargement of the breast
- Increased firmness of the breast
- Lumps in the breast
- Any change in the breast or the way the breast feels form normal
BIA-ALCL is Highly Treatable
“This is an extremely rare disease yet is highly treatable,” shares Adams. “Every patient that has ever been diagnosed appropriately and treated – the treatment of choice is a capsulectomy – has been cured.
A Proactive Decision by Allergan for Patient Safety
“I think this is a very proactive decision by Allergan,” shares Dr. Adams. “I think they are trying to support their patients as are the physicians.”
The best way for patients to get both proper information and have their personal situation assessed is by contacting their plastic surgeon. “If you have an Allergan textured implant, I would personally make an appointment to see your doctor to make sure everything is OK,” shares Dr. Pozner.