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 U.S Food & Drug Administration (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.
On 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.
The recall came after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is a cancer of the lymphatic system.
Currently, 38 other countries have recalled this implant because of its link to ALCL.
The FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.
Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.
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). Breast implants may also be used in revision surgery to correct or improve the result of a primary breast implant surgery. Tissue expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary (less than six months implantation under the skin (subcutaneous) or under the muscle (submuscular).
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Based on the currently available information, the FDA's analysis demonstrated 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, including death, from BIA-ALCL.
In February 2019, the FDA warned that breast implants may cause BIA-ALCL, a type of lymphoma. Unlike traditional breast cancer, which affects the breast tissue itself, this cancer develops within the scar capsule that forms around the breast implant during the healing process.
The link between breast implants and cancer was first identified in 2011, but a review of reports prompted the FDA to send out a larger safety announcement as well as contact doctors about the issue.
In early April 2018, France became the first country to ban certain textured breast implants due to their association with breast implant-linked lymphoma.
The disease that has come to be known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer.
Rather, it is a variant of the same lymphoma that has been linked to the use of the herbicide glyphosate, a malignancy that attacks the immune system, specifically targeting the white blood cells, or T-cells. According to the American Cancer Society, ALCL is the result of a genetic mutation, which causes the T-cells to produce excess quantities of a specific protein known as anaplastic lymphoma kinase or ALK-1.
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.
Studies That Strengthen The Cancer Link:
October 2020: A report was published in the medical journal JAMA Surgery, where South Korean researchers suggested an association between the use of textured breast implants and an increased risk of breast cancer relapse.
The study included 650 women, identified from a prospectively maintained database, who underwent 687 breast implant procedures, including tissue expanders and breast reconstruction, from January 1, 2011, to December 31, 2016. The patients were followed up for at least two years after the surgery, and an analysis was performed from February 15, 2020, to March 5, 2020. The analysis revealed that women who had textured breast implants faced three times the risk of relapse and significantly lower disease-free survival rate as compared to the ones who received implants with smooth surfaces.
September 2020: A study was published in the medical journal Plastic and Reconstructive Surgery-Global Open (PRS), in which Columbian researchers discovered that brands other than Allergan and Mentor were also found to be associated with BIA-ALCL.
According to the study, the researchers found 18 cases of BIA-ALCL in Columbia between 2011 and 2019. Out of these cases, seven were linked to Allergan implants, and three were linked to Mentor implants, both accounting for just above 55%. Additionally, Silimed Polyurethane implants were linked in two cases, and one each for implants manufactured by Eurosilicone, Nagor, Orion, and Poly Implant Prothèse (PIP).
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:
anuary 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 Legal Proceedings:
January 2021: Allergan USA Inc. files a supplemental brief in the U.S. District Court for the District of New Jersey, asking the federal judge to dismiss claims against its breast implants on pre-emption grounds.
October 2020: The FDA issues breast implant labeling recommendations and information regarding health complications, often referred to as “breast implant illness.”
August 2020: The FDA releases a report indicating that the number of BIA-ALCL cases increased by nearly 28% in the second half of 2019.
August 2020: Allergan, Inc. files a motion in the U.S. District Court for the District of New Jersey seeking dismissal of lawsuits on pre-emption grounds.
June 2020: Acting Administrative Director of the Courts, Glenn A. Grant, announced that all Allergan Biocell breast implant lawsuits filed in New Jersey will be consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims will be presided by Judge Rachelle Harz.
June 2020: The parent company of Allergan, AbbVie Inc., announced to launch a new awareness campaign to inform women implanted with its recalled Allergan Natrelle Biocell breast implants.
May 2020: The FDA issued a warning letter to Allergan, Inc., as the company failed to conduct post-approval studies on two different breast implant models, which were recalled last year over allegations that they might expose women to BIA-ALCL.
March 2020: The plaintiffs involved in the Allergan Biocell breast implant lawsuits asked the New Jersey Supreme Court to consolidate all the cases before one state judge for pretrial proceedings.
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.
