Allergan Breast Implants

Manufacturer 

 

Allergan Medical                                     $52.4 Billion

 

FDA Approval 

 

Natrelle Saline                                         P990074 – 5/10/2000
Natrelle Silicone-Filled                          P020056 – 11/17/2006
Natrelle 410 Silicone-Filled                   P040046 – 2/20/2013
Natrelle 133 Plus TE                                K143354 – 8/20/2015 
Natrelle 133 TE w/Suture Tabs             K102806 – 1/5/2011

 

MDL Information 

 

JPML hearing on 12/5/19

Background

It has been reported that there are approximately 300,000 breast augmentation and 150,000 breast reconstruction procedures performed annually in the United States.  Of these, approximately 5% involved textured breast implants. 
 
FDA reported 33 deaths worldwide
 
Deaths in U.S. were 36%
Allergan accounted for 36% of deaths
Unknown MFGs accounted for 61% of deaths
Allergan accounted for 92.3% (12/13) of deaths from known MFGs
 
FDA reported 320 cases of BIA-ALCL in U.S. through 7/6/19
 
Allergan (et al) accounted for 90.6% (481/531) of implants from known MFGs
Projected Allergan from unknown MFGs (90.6% of 42) = 38
Projected Allergan from 573 incidence = 519 (481+38)
Allergan (et al) – projected – accounts for 90.6% (519/531) of implants
 
Based upon projected Allergan implants and number of cases of BIA-ALCL in U.S. (320 cases), Allergan is projected to account for 290 cases of BIA-ALCL in U.S.
 
Macro-Textured implants like BIOCELL (Allergan) represent less than 5% of breast implants sold in U.S.
Textured implants account for only 10% of all breast implants sold in U.S.  Textured implants in France, Canada and France represent as much as 80% of their market share of total breast implants
 
Reported increased risk of acquiring ALCL is 6x greater with Allergan textured implants than with textured implants made by other MFGs
 
Study shows increased risk of acquiring ALCL is 14.11x greater with Biocell (Allergan) textured implants compared with Siltex textured implants.  Same study shows Silimed textured implants showed an increased risk of 10.84x greater than Siltex textured implants.
 
The lifetime risk of developing BIA-ALCL, from epidemiological studies and implant sales data from the U.S., Canada, Netherlands and Australia, ranges from 1:1,000 to 1:30,000 with textured implants.  The current lifetime risk of BIA-ALCL is estimated to be 1:2,207 - 1:86,029 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades.
 
In January 2018, a Dutch study estimated the risk of ALCL in women with breast implants to be: 
  • 1 in 35,000 for women at age 50
  • 1 in 12,000 at age 70
  • 1 in 7,000 at age 75
In the United States, approximately 300,000 breast augmentations and 150,000 breast reconstructions are performed annually.
 
Number of breast implants in the U.S. each year (American Society of Plastic Surgeons)
 
2011      307,000
2012      286,000
2013      290,000
2014      286,000
2015      279,000
2016      290,000
2017      300,000
2018      290,000*
 
Total      2,328,000
 
Incidence of BIA-ALCL (FDA)         1 in 3,817 to 1 in 30,000**
 
*Average since 2011
**Based upon medical device reports (MDRs)
If we assume that there are 300,000 breast augmentations and 150,000 breast reconstructions performed per year in the U.S. (450,000)
 
450,000 x 8 (2011-2018) = 3,600,000***
180,000 (5% of 3.6 million) involve textured breast implants
Assuming 100% of textured breast implants are Allergan, and the risk is 6x greater with Allergan, the incidence range would be 1 in 636 to 1 in 5,000****
Projected number of BIA-ALCL among Allergan textured implant recipients is 36 to 283 from 2011-2018 in the U.S.
 
If one assumes that MDAs are underreported (10%), projected number of BIA-ALCL among Allergan textured implant recipients is 360 to 2,830 from 2011-2018 in the U.S.
 
However, one must also consider that the lag time between current implant insertion to diagnosis of BIA-ALCL has been from 0.8-27 years, with a mean of 9.75 years, which would likely mean that the number of actual diagnosed cases is much lower.
 
***There are likely duplicates within this number – women with multiple surgeries
****There is a recent study in May 2019 that reported incident rate of 1/434 women with textured breast implants…slightly higher rate.
These are the following Allergan (or Allergan related) products and styles that are associated with the increased risk of BIA-ALCL and have been recalled:
 
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074.
 
The following are the textured styles associated with P990074:
 
  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 associated with P020056:
 
  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
  Implant
  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 associated with P040046:
 
  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

 

Treatment / Use

 
Textured implants are used because they develop scar tissue to stick to the implant, making them less likely to move around inside of the breast.
 
Implants are used for augmentation as well as reconstruction following breast cancer treatment.
 
Allergan, which includes McGhan and Inamed branded implants, has been manufacturing breast implants since at least 2000 when their Natrelle brand was given pre-market approval by the FDA.  Since then, they have received approval (PMA) for multiple brands of silicone and saline breast implants, including textured and smooth products.  In addition, used for reconstruction, Allergan received 510(k) approval for tissue expanders.

Injuries / Complications / Concerns

 
On July 24, 2019, the FDA made a request to Allergan, the manufacturer of a specific type of textured implant, to recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.
 
 
BIA-ALCL is not breast cancer - it is a type of non-Hodgkin's lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.
 
 
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.
These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. A list of Allergan's BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found at the end of this communication.
 
 
The FDA's analysis 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.
 
 
Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.

Information on the Topic of Allergan Breast Implants

 

Breast Implants: Australia and Ireland Take Action to Combat BIA-ALCL (10-21-2019)

https://medtruth.com/articles/news/mt-weekly-oct-21/

 

Allergan Skin Expander - Product Classification (8/19/2019)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=5961

 

Allergan Website – U.S. Affected Products List (8/13/2019)

https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/biocell-affected-products.pdf

 

The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication (8/7/2019)

https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue

 

Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (7/24/2019)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders (7/24/2019)

https://www.breastcancer.org/research-news/allergen-recalls-biocell-textures-implants

 

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market (7/24/2019)

https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

 

Allergan Recalls Textured Breast Implants Linked To Rare Type Of Cancer (7/24/2019)

https://www.npr.org/sections/health-shots/2019/07/24/744973282/allergan-recalls-textured-breast-implants-linked-to-rare-type-of-cancer

 

Risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3,546 women prospectively followed after receiving textured breast implants (5/26/2019)

https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.1565

Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants (3/2019)

https://www.ncbi.nlm.nih.gov/pubmed/30817554

 

FDA Warns of Increased Lymphoma Risk From Breast Implants (2/25/2019)

https://www.aafp.org/news/health-of-the-public/20190225breastimplants.html

 

Dutch Study Quantifies Breast Implant Anaplastic Large-Cell Lymphoma Risk (1/5/2018)

https://oncologypro.esmo.org/Oncology-News/OncologyNews-archives-2018/Dutch-Study-Quantifies-Breast-Implant-Anaplastic-Large-Cell-Lymphoma-Risk

 

Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk (10/2017)

https://www.ncbi.nlm.nih.gov/pubmed/28481803

 

Allergan Skin Expander - FDA 510(k) Application Details - K143354 (8/20/2015)

http://510k.medevnet.com/applications/index.cfm?id=K143354

Allergan Natrelle Highly Cohesive Silicone-Filled Breast Implants - Premarket Approval (PMA) (2/20/2013)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040046

 

FDA Update on the Safety of Silicone Gel-Filled Breast Implants (6/2011)

https://www.fda.gov/media/80685/download

 

Allergan Medical Skin Expander - FDA 510(k) Application Details - K102806 (1/5/2011)

http://510k.medevnet.com/applications/index.cfm?id=K102806

 

Allergan Medical Skin Expander - 510(k) Premarket Notification (1/5/2011)

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K102806

 

Allergan Natrelle Silicone-Filled Breast Implants - Premarket Approval (PMA) (11/17/2006)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P020056

 

Allergan Natrelle Saline Breast Implants - Premarket Approval (PMA) (1/18/2001)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P990074

Association of Breast Surgery – BIA-ALCL

https://associationofbreastsurgery.org.uk/clinical/bia-alcl/

 

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary