Recalled Breast Implants- Are Yours Recalled? Learn More

Hello, I'm Dr. Glenn Lyle, a board-certified plastic surgeon based in Raleigh, North Carolina . If you've heard about breast implant recalls and are wondering if yours may be affected, you're not alone. I want to clarify the facts and help you understand your options for peace of mind and optimal health.

Understanding Breast Implant Recalls

Breast implants can be recalled for safety reasons when health concerns arise. A medical recall doesn't mean immediate danger but highlights a potential risk that requires awareness and action.

Medical recalls are regulated by the U.S. Food and Drug Administration (FDA) to protect patient safety and ensure transparency.

Which Breast Implants Were Recalled?

Textured breast implants have been in use for decades, designed to reduce excessive scar tissue and help the implant stay in place. Unfortunately, some textured implants were linked to a rare condition called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of lymphoma.

The primary implants involved in recalls include:  

• Allergan Biocell Textured Breast Implants (Recalled July 2019)  
• Natrelle Textured Breast Implants (by Allergan)

According to the most recent data from the FDA, more than 1,079 cases of BIA-ALCL have been attributed to Allergan Biocell textured implants. This represents approximately 85% of all reported BIA-ALCL cases globally.

While 15% of cases have involved other manufacturers, Allergan voluntarily recalled the Biocell products due to the higher correlation.

Allergan continues to make smooth breast implants which are not felt to be high-risk and are considered very safe.

There are many Allergan implant brand or models associated with textured including style 163, 168, 110'115,120, 363, 468 as well as style 410. Also any Natrelle  device with a  "T " designation . A complete list is available on the FDA's website or Allegan's website.

If you want to know if your breast implant has been recalled, you should contact your original plastic surgeon's office.  Many patients still have their implant information as it is recommended to provide the patient with the implant identification card.

What are the Risks of BIA-ALCL?

Although the risk of ALCL is very low, it is up to 1 in  2200 patients with these Allergan implants and typically occurs at about 8 years postoperatively.  The disease is most frequently heralded by a late seroma or fluid collection around the breast implant.  

Fortunately, survival rates of this disease are very high.  Effective treatment includes complete removal of the implant and the surrounding capsule.  

Asymptomatic patients (patients without any symptoms) are advised to do frequent monitoring with physical exam and periodic ultrasound and/or MRI. 

Why Were These Breast Implants Recalled?

The recall occurred because of the connection between textured implants and BIA-ALCL, a rare but treatable lymphoma (type of cancer). Key factors in recalls include:  

• BIA-ALCL: Typically develops around 8 years post-surgery and often presents with fluid accumulation around the implant (seroma).  
• Structural Defects: Rupture risks and gel leakage in some models.  
• Manufacturing Defects: Inconsistencies in production leading to safety concerns.

Should You Remove Recalled Breast Implants?

The FDA does NOT recommend removing recalled implants if you are not experiencing symptoms. However, if you are concerned or symptomatic, consultation with a board-certified plastic surgeon is essential.

Regular health monitoring is recommended, including physical exams, ultrasounds, or MRIs to check for fluid accumulation.

Options When Removing or Replacing Breast Implants

If you decide to remove or replace your implants, I offer several surgical options tailored to your goals and optimal health:  

• Breast Implant Removal Only: Removal without additional procedures.  
• Breast Implant Removal with Lift (Mastopexy): To address sagging and reshape the breast after removal.  
• Breast Implant Removal with Fat Transfer: Using your body's fat to restore breast volume naturally.  
• Breast Implant Replacement: Swap the recalled implants for FDA-approved smooth implants. I routinely use smooth implants from Sientra, Allergan and Motiva.

Please Note: As a busy plastic surgeon in private practice these procedures are performed for self-pay patients as I no longer take insurance claim patients.

What About Implant Capsule Removal?

I perform a Partial Capsulectomy to remove part of the capsule when removal of the entire capsule would present a high likelihood of injury to the underlying chest wall or ribs or threaten entry into the lungs.    

• Total Capsulectomy implies the removal of all of the scar tissue (capsule) around the implant when removing the implant.   
• Total intact capsulectomy refers to cases when the intact implant is removed within the capsule.   
• En bloc capsulectomy is a term that is often misused. It is generally reserved for known ALCL cases as the surgeon removes an envelope or cuff of normal tissue with the capsule and implant. Enbloc removal is used to ensure all malignant cells are removed.  
• Many patients requesting an Enbloc procedure really mean an intact capsulectomy. En Bloc removal for concerns about Breast Implant Illness is not recommended by experts.

How to Check If Your Implants Are Recalled

If you're unsure whether your implants are part of the recall, here are the steps you can take:  

• Contact Your Original Surgeon: They may have your implant records.  
• Check Your Implant Card: Implant information is often provided to patients after surgery.  
• Consult the FDA Database: Visit the FDA’s official website for the latest recall list.  
• Visit Allergan's Website: They also provide a list of affected products.

What Are the FDA's Recommendations for Recalled Implants?

The FDA advises:  

• No Action Required for Asymptomatic Patients: Unless you have symptoms, routine removal is not recommended.  
• Monitoring: Regular follow-ups and imaging for early detection.  
• Consult a Plastic Surgeon: For personalized advice on removal or monitoring.

Latest Global Statistics on BIA-ALCL

As of June 2023, there have been 1264 reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide, including 63 deaths. This data represents a significant increase from previous reports, reflecting growing awareness and improved reporting of the condition.

Cases based on Implant surface type:  Macrotextured implants have 73% of reported cases and Smooth implant cases are rare but some cases reported.

A PRS 2024 Article estimated the occurrence of BIA-ALCL at 30.54 per 100,000 patients with textured implants (1 case per 3,274 implanted patients) and 6.70 per 100,000 patients with implants of any type (1 case per 14,925 implanted patients)

These statistics highlight the rarity of BIA-ALCL but also underscore the importance of ongoing surveillance and research into this condition.

Making Safer Breast Implant Choices

If you're considering replacing your implants, rest assured there are safe options available, including:  

• Smooth Silicone and Saline Implants: Lower risk compared to textured implants.  
• Fat Transfer: A natural alternative using your body’s own fat for subtle enhancement.

Final Thoughts

Your health and peace of mind matter. If you have concerns about your breast implants or want to explore your options for removal or replacement, I’m here to help. As a board-certified plastic surgeon in North Carolina, I’m committed to patient safety and personalized care.

For more information or to schedule a consultation, contact my office directly. Together, we can ensure your long-term health and confidence.

Medical References 

• Breast Implant-Associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk - Ann Surg. 2020 Sep 1;272(3):403–409  
• Estimating the prevalence of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) - a systematic review Plast Reconstr Surg 2024 Sep 23. doi: 10.1097/PRS.0000000000011768.  
• FDA Report at 30 June 2023 - Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma  
• The Capsule Question: How Much Should Be Removed with Explantation of a Textured Device? Nahabedian,M.Y. Plast. Reconstruct.Surg.147(5S): 44S,2021  
• Not All Breast Explants are Equal: Contemporary Strategies in Breast Explantation Surgery. Tanna,N et al Plast. Reconstruct.. Surg. 147: 808,2021 

About Dr Lyle - Plastic Surgeon in Raleigh NC

Dr. Glenn Lyle is a board-certified plastic surgeon serving the Raleigh, NC community at Lyle Plastic Surgery & Aesthetics Center since 2002. With over 30 years of experience, he specializes in breast surgery and body contouring, to enhance patients' appearance after weight loss, pregnancy, and aging. 

Dr. Lyle completed his medical degree at Wayne State University School of Medicine, followed by a general surgery residency at the University of Massachusetts and a plastic surgery residency at the University of Texas Medical Branch. He is certified by the American Board of Plastic Surgery and is a member of both the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgeons. 

Throughout his career, Dr. Lyle has contributed to the field through research, publications, and presentations at national meetings. His practice emphasizes patient safety and personalized care to achieve natural results.

Next Steps

If you’re considering a breast implant surgery in Raleigh, NC, and want personalized advice about your suitability, recovery, risks and results, I’d be happy to meet with you for a consultation. Let’s work together to help you achieve your best results—safely and beautifully.

To book a consultation please fill in the contact form or phone the office