Allergan Breast Implants

  • Allergan-Breast-Implants-Medical-Record-Review-Outsourcing Services

Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received  approval from the FDA on 11/17/2006.

The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma.

What Is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of T-cell lymphoma that occurs in some people who have had breast implants. It is not breast cancer but rather is a cancer of the immune system. The disease may affect a very small number of women who have received breast implants, primarily of the textured (rough) type. The lymphoma occurs in the scar tissue (fibrous capsule) that surrounds the implant, and in more advanced cases, may spread to lymph nodes that are near the breast.

Women who have undergone a mastectomy to treat breast cancer go on to have one or both breasts reconstructed, which can be done in two ways:  using tissue transplanted from another part of your body, or inserting an implant that's filled with saline (saltwater) or silicone gel.

A saline implant consists of a silicone shell that is filled with saline and silicone gel implants are filled with firm silicone gel, which is believed to have more like natural breast tissue.

Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. ALCL can develop in and around the tissue capsule.

According to the FDA, the risk of ALCL is higher in women with textured implants, which have a bumpy surface, as opposed to smooth implants.

Recalled Products:

The recalled Allergan products include:

  • Natrelle saline breast implant styles 168, 363, 468.
  • Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX.
  • Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX.
  • Natrelle 510 Dual-Gel styles LX, MX, FX.
  • Natrelle Inspira breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX.
  • Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch.
  • Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM.
  • Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM.
  • Natrelle 150 Full Height and Short Height double lumen implants.
  • Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T.
  • Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T.

The recall does not affect Allergan’s Natrelle smooth or Microcell breast implants and tissue expanders.

Serious Alleged Injuries may include:

  • Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
  • Breast Implant Lymphoma or Cancer
  • Non-Hodgkins Lymphoma Following Breast Implant
  • Late Peri-Implant Seroma
  • Peripheral T-Cell Lymphoma
  • CD-30 Expressing T-Cell Lymphoma
  • Breast Implant T-Cell Lymphoma
  • Other Non-Breast Cancer Lymphoma

FDA Safety Warnings:

January 2011: The FDA first reported a possible link between both saline and silicone breast implants and ALCL in the tissue near the implant.

2017: The FDA announced BIA-ALCL (Breast Implant-Associated-Anaplastic Large-Cell Lymphoma) was primarily associated with textured implants.

March 2018: The FDA announced that it is aware of about 400 cases of breast implant lymphoma worldwide.

July 24, 2019: Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.

Legal Updates:

Defendants:

Allergan, Inc.

Defendant Law Firm:

Allergan is represented by Shook Hardy & Bacon LLP.

Allegations: The lawsuits allege that the textured design was unreasonably dangerous and defective, and the manufacturer knew that it increased the chances of getting BIA-ALCL but failed to warn about those risks.

Plaintiffs’ Liaison Counsel:

James Cecchi - Carella, Byrne, Cecchi, Olstein, Brody & Agnello, PLC

Lawsuit Status:

According to data released by the FDA, around 573 known cases of breast implant ALCL have been diagnosed worldwide, including at least 33 deaths. Out of the known cases, 481 have been linked to breast implants sold by Allergan, which have been involved in at least 12 of the 13 deaths where the manufacturer of the breast implant was known.

Allergan Biocell Textured Breast Implant products liability lawsuits were consolidated on October 3, 2019, under MDL No. 2921 presided by the U.S. District Judge for the District of New Jersey Brian Martinotti and the U.S. Magistrate Judge for the District of New Jersey Joseph A. Dickson.

MDL Status: Active and on appeal.

Important Verdicts & Settlements: Currently there are no settlements made.

Evidence:

  • Duration of Usage
  • Indication of usage in Medical Records
  • Evidence of injury in follow up medical records

Medical Record Review and claim validation of Allergan Breast Implants case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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