Breast Implant Cancer
Some breast implants, both saline and silicone, have been linked to an increased risk of cancer called, BIA-ALCL, a non-Hodgkin lymphoma. The FDA recommends that patients considering implants be warned of the risk of serious complications, including fatigue, joint pain and the possibility of this cancer.
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Breast Implant Recall
The FDA’s safety communication for patients follows a worldwide recall of BIOCELL textured breast implant products, due to an increased risk of Breast Implant Associated Anaplastic Large Cell Lymphoma, BIA-ALCL, a type of non-Hodgkin lymphoma. Allergan products recalled include:
- Natrelle Saline-Filled breast implants,
- Natrelle Silicone-Filled breast implants,
- Natrelle Inspira Silicone-Filled breast implants, and
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
- tissue expanders Natrelle 133 Plus Tissue Expander and
- Natrelle 133 Tissue Expander with Suture Tabs
BIA-ALCL is typically in scar tissue and fluid near the implant, but may spread throughout the body. Patients exhibit late-onset symptoms, such as:
- breast asymmetry
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.
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
The U.S. Judicial Panel on Multidistrict Litigation will hear the petition to create a MDL docket for Allergan’s Biocell textured breast implant claims on December 4th, 2019 at a hearing in Austin.
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.;
- 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 consult. Deadlines apply, so contact us now.