Allergan voluntarily issued a worldwide recall of its line of BIOCELL textured implants and tissue expanders on July 24, 2019, after the U.S. Food and Drug Administration (FDA) determined these particular devices increase women's risk of developing a rare cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Of the 573 unique cases of BIA-ALCL the FDA has received since 2011, 481 are directly tied to Allergan BIOCELL textured implants and tissue expanders. Noting the connection, the agency made a request for Allergan to remove the products from the market, and the manufacturer complied.
What is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)?
BIA-ALCL is a T-cell lymphoma in non-Hodgkin’s form. The cancer cells are often found close to the breast implant, inside the fibrous scar capsule that surrounds it. The time for symptoms to occur is on average 8 years after breast augmentation and common symptoms like fluid buildup and persistent swelling change the appearance of the breast(s).
With early intervention, BIA-ALCL can be successfully treated by removing the implant and the capsule. For later stages, if the cancer cells have spread, more aggressive treatment such as chemotherapy may be required.
What makes Allergan BIOCELL textured implants a risk factor for BIA-ALCL?
It’s not well understood why, but experts believe the greater surface area and porous shell of textured implants like Allergan BIOCELL, Silimed Polyurethane, and Mentor Siltex could make them ripe for bacteria formation and growth. If the bacteria trigger an infection, the body can develop an immune response (chronic inflammation) that eventually leads to BIA-ALCL.
Other potential risk factors include reactions to the silicone shell of the implant, genetics, and long-term allergies. Saline and silicone fill seems to play no role or increase one’s risk.
Allergan BIOCELL breast implants, compared to other manufacturer's textured implants, may pose a risk 6 times greater because they contain a level 3 textured surface, which means they are more texturized. They have a larger surface area, too. Allergan’s MICROCELL implants, which have a level 2 textured surface, for example, are not part of this voluntary recall.
What is your risk of developing BIA-ALCL if you have textured implants?
The FDA still considers the overall risk of contracting BIA-ALCL to be low in the U.S. (at 1 in 3,817 to 1 in 30,000), citing textured implants only account for 10 percent of all breast implants sold in the nation and of those, Allergan’s textured implants make up less than 5 percent.
However, in France, Canada, and Australia, where the use of textured implants is as high as 80 percent, the risk is elevated to 1 in 1,000 and 1 in 10,000. These countries have already enacted recalls on certain textured implants, including some sold by Allergan.
What does a voluntary recall of Allergan BIOCELL textured implants mean?
From the market perspective, the recall recommends that plastic surgeons immediately stop using these implants in surgical procedures and return them to Allergan.
Healthcare providers have been provided guidelines and recommendations for what to watch for and what steps are necessary to diagnose BIA-ALCL as early as possible. This includes reporting of new or suspected cases to the FDA's Adverse Event Reporting program, MedWatch.
What to do if you have Allergan BIOCELL textured implants or other textured implants
The FDA has certain recommendations for those with textured implants who are and aren't experiencing symptoms.
No symptoms
The agency and American Society of Plastic Surgeons (ASPS) currently do not recommend removal of any textured implants, including the Allergan BIOCELL implants, if you have no symptoms. The overall risk of development of BIA-ALCL is low and removal could result in unnecessary surgical procedures and added cost.
Other recommendations are:
- Know the symptoms of BIA-ALCL. Persistent swelling or pain near the breast implant from fluid accumulation around the implant, unexplained enlargement of the breast(s), a lump in the breast(s) and/or armpit, hardening of the breast, and skin rash are signs that could signal BIA-ALCL.
- Monitor your breasts regularly. Continue your monthly breast exams and be aware of the normal shape and size of your breasts. Feel for lumps and look for changes in appearance.
- Keep up with your breast implant ID card and warranty. In the event complications occur, you want to have a record of who the manufacturer is and the implant model name. You'll also want access to the details of your warranty coverage. The Allergan warranty currently offers aid for some BIA-ALCL events.
Follow the FDA and ASPS to stay up to date on the current recommendations as these may change over time.
Symptoms
- Follow up with your care provider with any concerns. If you experience any BIA-ALCL symptoms or other changes, see your health care provider. A biopsy, ultrasound, MRI, and blood tests can be done to evaluate fluid or masses of the breasts. Any fluid found will be tested for CD30, which is an indicator for lymphoma cancers.
- Get treated if you are diagnosed. Early-stage BIA-ALCL can be successfully treated by removing the implant and entire scar capsule around the implant. If the cancer has spread, lymph node removal and cancer treatments like radiation may be necessary.
- Report your symptoms. The FDA encourages you to use the MedWatch Voluntary Reporting Form if you suspect or experience a problem. Have your breast implant ID card available to provide product details.
What if you are considering a breast augmentation?
First, do your research to learn about breast augmentation and implant options. There are several article libraries available online to help improve this understanding, and the FDA has a comprehensive list of considerations you should take into account before undergoing surgery.
Once you have a grasp, consult with a board-certified plastic surgeon to discuss the risks and benefits of the procedure and to determine how implants may affect you personally.
Which Allergan textured breast implants have been recalled?
The FDA has named the following products for recall:
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant)
- Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
- Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
- Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
- Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants)
- Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
- Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
- Style 120 - BIOCELL Textured Round High Projection Gel Filled Breast Implants
- Style TRL - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRLP - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRM - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRF - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRX - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants
- Style 410FM
- Style 410FF
- Style 410MM
- Style 410 MF
- Style 410 FL
- Style 410 ML
- Style 410 LL
- Style 410 LM
- Style 410 LF
- Style 410 FX
- Style 410 MX
- Style 410 LX
Allergan tissue expanders for the breast that have BIOCELL texturing
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
References:
FDA. (2019). The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
FDA. (2019). FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
FDA. (2019). Things to Consider Before Getting Breast Implants. Retrieved from https://www.fda.gov/medical-devices/breast-implants/things-consider-getting-breast-implants
FDA. (2019). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
American Society of Plastic Surgeons. (2019). Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.plasticsurgery.org/patient-safety/bia-alcl-summary?fbclid=IwAR2poSa_oipJhMv_9S6rpKpOnzS5qlWOlq_v5nhVLyQcWi_ms_nYuZQgHbw
FDA. (2019). Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Retrieved from https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
Allergan. (2019). Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders. Retrieved from https://www.allergan.com/news/news/thomson-reuters/allergan-voluntarily-recalls-biocell-textured-brea.aspx?fbclid=IwAR0SPo9cEgDll3A-rZ_SrFNjJOrmmqmVkCD-8h0kpfI5SZ1Vpu1UlklOTlY
Therapeutic Goods Administration. (2019). Update - TGA's review of textured breast implants and preliminary outcomes. Retrieved from https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
Jones P, Mempin M, Chowdhury D, et al. (2018). The Functional Influence of Breast Implant Outer Shell Morphology on Bacterial Attachment and Growth. Plast Reconstr Surg. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/30252806
