The U.S. Food and Drug Administration (FDA) on Friday (July 25, 2019) issued an alert about textured breast implants and Biocell tissue expanders, produced by Allergan, as they are related to the onset of anaplastic large cell lymphoma (BIA-ALCL).

Allergan is located in Costa Rica’s Global Park zona france (free zone) in Barreal de Heredia. Image Shutterstock

The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices.

Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

According to the FDA Safety Communication, the recall was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.

Costa Rica’s Ministerio de Salud (Ministry of Health) also joined the FDA recall.

The Allergan manufacturing plant is located in Costa Rica where production is concentrated in the development of breast implants.

“For us the most important thing is the health of our patients, so we abide by the suggestion immediately and we are making the voluntary removal of all the implants we have of this type in the world,” said Nelson Rodriguez, Allergan’s vice president in Costa Rica.

At this time, Biocell textured implants are not being marketed and only microcell and smooth are for sale, Rodriguez told La Teja.

“These studies take years and this is only a suspicion, there is nothing proven, but we are voluntarily withdrawing our products as a preventive measure,” said Rodríguez.

Allergan is a leading breast implant production company and ranked 12th in the Top 50 Global Pharma Companies ranking in 2018.

Recommended actions

The National Center of Technovigilance (CNTV) of the Health Products Regulation Department of the Ministry of Health followed up on the FDA alert issued, so it recommended to suspend the application of Biocell implants.

In addition to quarantine, both the implants and tissue expanders and ask for their return from distributors and marketers of the products; Inform patients about the risk of developing said cancer; and give patients all the data of the implant to maintain the traceability of the product.

Another suggestion is that medical practitioners should inform patients about the risk of developing anaplastic large cell lymphoma; The Ministry of Health statement warns that it is not recommended that women remove implants or tissue expanders because the risk of disease is low.

In addition, the user must continue with the routine medical follow-up and if changes occur in her breasts after surgery – such as swelling or pain around the implant – she should immediately notify their doctor.

The Ministry of Health also reminded patients on the importance of keeping the manufacturer’s record, the device identifier, the name, and the model. In the event that the person does not have such information, the recommendation is for the patient to consult the doctor who performed the surgery.

The majority of patients who develop anaplastic large cell lymphoma do so many years after the procedure, so it is important that the user keep a follow-up with the specialist.

Report

In Costa Rica, women who have any suspicion associated with the use of these implants can report it via the Internet using the official form available at www.ministeriodesalud.go.cr or to the National Center of Tecnovigilancia, located at the Ministry of Health in San José, North Building, 4th floor. Or by phone 2257-2090.

In the United States, if you have questions about this recall, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 1-800-638-2041 or 301-796-7100.

Affected Products

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)