July 24, 2019 — Pharmaceutical giant Allergan has ordered the recall of all of its BIOCELL textured breast implants after the FDA flagged a series of reports that the implants were causing cancer in hundreds of patients worldwide.
The FDA says the textured surface, unique to Allergan’s implants, are tied to 481 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. There have been 573 cases of BIA-ALCL worldwide, including 33 deaths. In 13 cases where a patient died and the manufacturer of the breast implant was known, 12 of them involved an Allergan breast implant.
Most cases of this particular cancer, which attacks the immune system, are not diagnosed for years after the original implantation.
Daniel Maman, MD, a board-certified plastic surgeon with 740 Park Plastic Surgery in New York City, says it remains unclear why these types of implants could cause cancer.
“But these rare cases are showing that the texture of the shell surrounding the implant can cause this lymphoma response in capsule tissue that surrounds the breast implant,” he says.
The FDA says anyone with an Allergan BIOCELL implant should not have it removed, unless symptoms are present. Those symptoms include persistent swelling or pain near the implant. Patients found to have BIA-ALCL would have the implants removed, along with surrounding scar tissue.
The FDA says in most cases, the cancer is limited to the scar tissue and fluid near the implant, but it can spread through the body. While the diagnosis is serious and can lead to death, the risk is considered to be low, the agency says. Some patients may need chemotherapy and/or radiation therapy.
The FDA says the risk of getting BIA-ALCL from an Allergan textured implant is roughly 6 times the risk compared to similar products from other manufacturers. Textured implants represent 10% of all breast implants sold in the United States.
“The popularity of the different types of implants is heavily dependent on the surgeon and what they prefer using, but there are pros and cons of each type of implant,” Maman says. “I personally have not put in a textured implant in over 5 years.”
The recalled products are:
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:
- 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) approved under P020056. The following are the textured styles:
- 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 approved under P040046. The following are the textured styles:
- 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 originally cleared as:
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)