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Breast Implant Cancer

Some breast implants, both saline and silicone, have been linked to an increased risk of cancer called, BIA-ALCL, breast-implant associated anaplastic large cell lymphoma a non-Hodgkin lymphoma of the immune system. The FDA requested that Allergan recall its BIOCELL® textured breast implants and tissue expanders due to increased risk of a rare cancer. Saline and silicone implants, tissue expanders, some implants formerly called McGhan and Inamed are included in the list that follows.

BIA-ALCL is typically found in scar tissue and fluid near the implant, but may spread throughout the body.  Patients exhibit late-onset symptoms,  such as:

  • pain,
  • lumps,
  • swelling,
  • breast asymmetry

BIA-ALCL can spread throughout the body and can lead to death 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. It is critical to have the correct testing, diagnosis and undergo treatment.

According to Dr. Mark W. Clemens II, a plastic surgeon and expert on ALCL at the University of Texas MD Anderson Cancer Center in Houston, “only about 30 percent of plastic surgeons were routinely discussing the cancer with patients” as of 2015. Diagnosis of this type of BIA-ALCL cancer requires a test for a substance called CD30 which is conducted by collecting and examining fluid around the implant. If not tested correctly, the disease can easily be mistaken for others, and doctors may order rounds of unnecessary chemotherapy and radiation for patients that ultimately cause more harm than good while not treating the underlying problem.

Most patients will have spontaneous fluid collection; 40 percent will feel a mass or lump. Diagnosis of BIA-ALCL is possible with a screening test called CD30 and can be missed without adequate screening.

Contact Us

We have been litigating breast implant claims for the past three decades. Contact us at 1-800-814-4540, email carolyn@carolynstclair.com or fill out the contact form for a free medical legal consultation.

Breast Implant Recalls: Manufacturers & Products

ALLERGAN NATRELLE SALINE-FILLED BREAST IMPLANTS (FORMERLY MCGHAN RTV SALINE-FILLED Mammary Implant) approved under P990074. Textured styles include:

  • 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. Textured styles include:

  • 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. TEXTURED STYLES INCLUDE:

  • 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 THAT HAVE BIOCELL TEXTURE originally cleared as:

  • Natrelle 133 Plus Tissue Expander (K143354)
  • Natrelle 133 Tissue Expander with Suture Tabs (K102806)

Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.

Allergan Biocell Textured Breast Implant MDL

Cases are consolidated in MDL 2921 before Judge Brian Martinotti and Judge Joseph Dickson in New Jersey federal district court.  No trials have been scheduled.

FDA MedWatch Alert

The FDA Breast Implant Cancer Hearings reveal the survivors’ stories of anaplastic large cell lymphoma. The FDA mandated a Letter to Health Care Providers warning that Breast Implants are linked to Anaplastic Large Cell Lymphoma. 10 to 11 million women worldwide have breast implants with data indicating the ALCL-BIA occurrence more frequently in implants with a textured surface than in smooth surface implants. However, ALCL can occur in both saline and silicone implants. The FDA cautions that patients with smooth surface implants are still at risk of developing ALCL. The reality is most patients are not likely to be aware of what surface their implants consist of, and multiple factors may contribute to the develop of ALCL, including patient characteristics, operative procedure history, implant characteristics and duration of placement.

Breast Implant Manufacturers

Currently in the United States, there are FDA-approved implants manufactured by

  • Ideal Implant, Inc.;
  • Allergan;
  • Mentor (Johnson & Johnson); and
  • Sientra, Inc.

Lawsuits have been filed against Allergan and Johnson & Johnson on behalf of breast implant patients diagnosed with BIA-ALCL.

The World Health Organization, Plastic Surgery Foundation and regulatory bodies have all recognized BIA-ALCL as a unique form of ALCL and have provided information and resources regarding the disease.

Recall in Europe

Breast implants have been recalled in Europe due to the risk of BIA-ALCL. The implants manufactured by Allergan are textured breast implants. The manufacturer said it “has suspended sales of textured breast implants and tissue expanders and is withdrawing any remaining supply” in Europe. It will still be offered in the U.S.

If you or a loved one has been diagnosed with BIA-ALCL, contact us at 1-800-814-4540 for a free consultation. Hospitals destroy medical records after a certain time period, so contact us now at 1-800-814-4540 or email carolyn@carolynstclair.com. 

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