Allergan Implant Recall

2019 Allergan Textured Breast Implant Recall

In an August 2019 Safety Communication, the FDA requested that Allergan voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market for the safety and protection of patients.

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market.

This recall was based on Medical Device Reports that demonstrated worldwide cases of BIA-ALCL as well as Breast Implant Associated-Anaplastic Large Cell Lymphoma related deaths linked directly to these Allergan Textured Implants. The evaluation of these reports led the FDA to conclude that the risk of BIA-ALCL with Allergan BIOCELL textured implants is roughly SIX TIMES higher than the risk associated with textured breast implants made by other manufacturers.

History of FDA Breast Implant Regulations FDA

The 2019 Allergan Implant Recall was just the latest in a long and complex relationship between breast implants and the FDA. Below is a brief timeline of this history:

  • 1982 – The FDA considers placing breast implants into the Class III category following “reports of adverse events in the medical literature.” This change would require manufacturers to prove their safety in order to remain on the market.
  • 1988 – FDA classification of breast implants as Class III goes into effect. All silicone breast implant manufacturers must prove both their safety and effectiveness prior to Pre-market Approval (PMA).
  • 1991 – When manufacturers of silicone implants submit products for PMA, the FDA requests additional data after concluding that the manufacturers safety data did not prove the implants were safe.
  • 1992 – The FDA revisits the issue of breast implant safety and recommends that their use be limited to reconstruction only.
  • 2006 – FDA approves Allergan pre-market approval for silicone breast implants for reconstruction, augmentation, and revision. A stipulation for this approval was that Allergan must conduct 6 post-approval studies.
  • 2011 – FDA releases first statement on the occurrence of Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. Later this year, the FDA issues a Safety Update acknowledging that “women with breast implants may be more likely to be diagnosed with ALCL. At this time, there are 60 identified cases since 1997.
  • 2014 — American Society of Plastic Surgeons (ASPS) ordered a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by 3 breast implant manufacturers. The final information was accepted by the FDA advisory board on 8/1/2014.
  • 2018 – In November, the ANSM (France’s equivalent to the US FDA) recommends against the use of textured breast implants. By December, this recommendation has escalated to a compulsory recall of Allergan’s BioCell Textured implants. Allergan then voluntarily recalls BioCell products in all 38 countries that require CE Marking.
  • 2019 – In March, the FDA’s General & Plastic Surgery Devices panel held a 2-day public meeting to further discuss BIA-ALCL and breast implant safety. This month the FDA also sent warning letters to manufacturers who failed to conduct sufficient safety studies as previously required. Following France’s lead, a European-wide ban of Allergan BIOCELL was issued in April leading to the Safety communication mentioned above as well as an FDA Class I recall of Allergan Textured Breast Implants on September 12, 2019.

FDA Class I Recalls are the most serious type of recall indicating that the use of such devices may cause serious injuries or death.

Products Included in FDA Breast Implant Recall

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)

Allergan Implant Lawsuit Claims

If you or a loved one received Allergan Textured implants for either cosmetic breast augmentation or postmastectomy reconstruction, you may be entitled to financial compensation. We know that every step of the claims process is riddled with confusion and potential legal hurdles. The Willis Law Firm is a leading personal injury firm in Houston, TX with recognition nation-wide. Mr. Willis has been practicing law for over 35 years and is a board certified Personal Injury Trial Attorney. Along with his talented and enthusiastic team, he is ready to help evaluate your potential claim as well as guide you towards the compensation you deserve. All clients are represented on a contingency fee basis – if you we do not recover for you, then you don’t pay!