In July 2019, the Food and Drug Administration (FDA) issued a recall of Allergan Biocell textured breast implants and tissue expanders due to a link between them and a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA recommended that patients with these implants should receive follow-up care from their healthcare providers, including regular physical exams and imaging tests as needed.
The recall affects all Allergan Natrelle saline-filled breast implants, silicone gel-filled breast implants, and tissue expanders sold worldwide since July 2010. Allergan’s products are some of the most popular on the market, accounting for about one-third of all breast implants used in the United States.
The FDA noted that while it is not yet clear what causes BIA-ALCL, there is evidence that suggests textured implants may increase the risk. Textured implants have a rougher surface than smooth ones, which may be more likely to cause irritation or inflammation that could contribute to cancer development. The FDA also pointed out that women with any type of implant may still develop BIA-ALCL, but the risk appears to be higher with textured ones.
The recall has caused concern among many women who have had these types of implants, as well as those considering them for cosmetic or reconstructive surgery. It is important for patients to understand their risks and talk to their healthcare provider about any questions or concerns they may have.
Causes of the Recall
In July 2019, Allergan, a major medical device manufacturer, issued a worldwide recall of their Biocell textured breast implants and tissue expanders. The recall was prompted by the link between these products and the development of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is a rare type of cancer that affects the immune system and can form in the scar tissue surrounding breast implants.
Link to BIA-ALCL
The link between Allergan’s Biocell textured breast implants and BIA-ALCL was discovered by researchers at the National Cancer Institute (NCI) and Food & Drug Administration (FDA). Their research found that women with textured implants had a higher risk of developing BIA-ALCL than those with smooth implants. This research prompted Allergan’s recall as well as additional warnings from both NCI and FDA about the potential risks associated with textured implants.
Symptoms and Treatments
The symptoms of BIA-ALCL vary from patient to patient but may include swelling, pain or lumps around the implant area. If left untreated, it can spread to other parts of the body and become more serious. Treatment for BIA-ALCL typically involves removal of the affected implant as well as any surrounding scar tissue. In some cases, chemotherapy may also be necessary. It is important to note that not all patients with textured implants will develop BIA-ALCL; however, it is important to be aware of the potential risk when considering breast implant surgery.
Impact on Patients
The Allergan breast implant recall has had a significant impact on patients who have received the Biocell Textured implants. The uncertainty of the potential risks associated with the implants has caused many women to worry and seek medical advice.
Rate of Developing ALCL from Allergan Biocell Textured Implants
According to the FDA, as of February 1, 2021, there have been 573 confirmed cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) worldwide, including 33 deaths. Of these cases, 571 were linked to textured implants and two were linked to smooth implants. Of the 571 cases associated with textured implants, 481 were attributed to Allergan Biocell Textured Implants specifically. Additionally, an analysis conducted by the FDA found that out of every 100,000 patients who receive textured breast implants, approximately one will develop BIA-ALCL over a period of 10 years.
Comparison to Breast Cancer Risk
Although the risk of developing BIA-ALCL is relatively low compared to other forms of cancer, it is important to note that this risk is much higher than that associated with breast cancer. According to the American Cancer Society, the average lifetime risk of developing invasive breast cancer in women is 12%. This means that for every 100,000 women who receive textured breast implants, approximately 12 will develop breast cancer over a period of 10 years compared to one case of BIA-ALC
The risk associated with Allergan Biocell Textured Implants specifically is even lower than this general estimate as the FDA’s analysis found that out of every 100,000 women who receive these specific implants only 0.21 will develop BIA-ALCL over a period of 10 years. This number is significantly lower than the estimated lifetime risk for invasive breast cancer in women which underscores how rare this type of lymphoma is in comparison.
Liposuction NYC Specialty Clinic Response
We are committed to providing our patients with the highest quality of care. We take all recalls and warnings seriously and strive to ensure that our patients have access to the most up-to-date information about their treatment options.
In light of the recent recall of Allergan Biocell Textured Breast Implants due to a potential link with Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), we are taking proactive steps to ensure patient safety and satisfaction.
Education
We are educating our patients on the potential risks associated with breast implants as well as the symptoms and treatments for BIA-ALC We are also informing them of other implant options available should they choose not to use Allergan products.
Testing
Our practice is also testing all implants in-house for any signs of deterioration or contamination prior to implantation. We also conduct regular follow-ups with our patients who have already received Allergan Biocell Textured implants in order to monitor their health and wellbeing.
Support
Finally, we are offering counseling and support services for those who may be feeling anxious or overwhelmed by the news of the recall. Our staff is available 24/7 by phone or online chat if you have any questions or concerns about your implants.
We understand that this news can be very concerning for those who have already received Allergan Biocell Textured Breast Implants, as well as those considering them in the future. We want you to know that we are here for you every step of the way and will do everything in our power to ensure your safety and satisfaction.
Conclusion
The Allergan breast implant recall has been a cause for concern for many women who have had their implants done. The recall is due to the link between BIA-ALCL and the textured Biocell implants. Symptoms of BIA-ALCL include swelling, pain, and lumps in the area of the implant. Treatment for this condition includes removal of the implant and surrounding tissue.
The risk of developing ALCL from Allergan Biocell Textured Implants is much higher than that of developing breast cancer. Because of this, it is important to be aware of the risks associated with these implants and to discuss them with your doctor before undergoing any kind of cosmetic surgery.
We are committed to providing our patients with safe and effective treatments. We take all necessary precautions when performing surgeries, including reviewing product recalls prior to use. Our team is available to answer any questions or concerns you may have about breast implants or other procedures we offer.
Overall, it is important to be aware of the potential risks associated with breast implants and other types of cosmetic surgery before making a decision. It is also essential to do research on any products or treatments you may be considering so that you can make an informed decision that is best for your health and safety.