Allergen Breast Implants are the Subject of Worldwide Recall
Now banned worldwide, textured breast implants are linked with the occurrence of a rare cancer in women.
The number of women undergoing breast augmentation in the United States continues to rise. According to the American Society of Plastic Surgeons (ASPS), breast augmentation led the list of cosmetic surgical procedures performed in 2017. In that year alone, the number of augmentation procedures rose three percent from 2016.
Whether performed for cosmetic or reconstructive reasons, breast augmentation usually involves insertion of implants in the chest. Implants may contain saline or silicone with exterior coverings that are either smooth or textured. In recent years, implants with a textured exterior have led to warnings, then outright bans, as they have become linked with a rare cancer.
Since the US Food and Drug Administration (FDA) reported on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in 2011, studies have added to our knowledge of the disease. Here are some points about the implants and BIA-ALCL:
- The FDA recommends healthcare providers immediately cease using Allergan BIOCELL breast implants. There are other manufacturers of textured implants, but Allergan implants have been implicated in a majority of the cases where the implant could be identified. At present, 573 cases of BIA-ALCL have been reported worldwide with 33 deaths. Of that total, 481 of those cases are related to Allergan products. Allergen textured implants were taken off the European market in 2018, with a global recall following in July of 2019.
- BIA-ALCL is not a cancer of the breast tissue. It is a lymphoma, or a type of cancer that begins in the immune system of the body. Deeper texturing of the exterior covering of Allergan implants could offer better growing conditions for bacterial growth once surgically implanted. Some experts suggest growth of a bacterial biofilm on the implants may contribute to development of the lymphoma. Initially, cancerous cells remain within the fibrous capsule that forms around the breast implant. If treated at this point, removal of the implant and the fibrous capsule can often cure the cancer. If untreated, cancerous cells can spread throughout lymphatic fluid in the body, leading to less positive outcomes.
- Symptoms of BIA-ALCL include breast lumps or asymmetry, pain, fatigue, and swelling. Your physician can evaluate for BIA-ALCL through imaging, examination, or biopsy of fluid around the implant.
While BIA-ALCL impacts only a portion of women with breast implants, it is sobering to take note of guidance provided by the FDA, “at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.”
The number of women suffering from BIA-ALCL will rise. Hopefully, knowledge and early intervention will prevent or deter needless suffering and untimely death. If you, or a loved one, received breast implants, speak with your physician for guidance.
If you have already received a cancer diagnosis related to your implants, speak with a knowledgeable injury attorney to discuss your options.
Experienced Attorneys help clients in Baltimore, Washington DC, and across the United States
Schochor, Federico and Staton, P.A. is a nationally recognized law firm with a successful track record of fighting for compensation for individuals and families harmed by medical mistake. If you have been diagnosed with BIA-ALCL, contact us today to schedule a free consultation.