Why Were Allergan’s Textured Breast Implants Taken Off the Market

Rare Cancer Associated with Textured Breast Implants Leads to a Worldwide Recall

Allergan, the largest breast implant manufacturer worldwide, issued a voluntary global recall of Biocell textured breast implants and tissue expanders following a request from the U.S. Food and Drug Administration (FDA) to pull them from the market. A very rare type of cancer known as anaplastic large-cell lymphoma (ALCL – BIA) has been linked to these textured implants. Although the prevalence of ALCL-BIA in patients with textured implants is incredibly small (it is estimated to be diagnosed once in every 2,800 to 30,000 patients), this association has raised concerns about the safety of textured implants. To date, 573 women have been diagnosed with textured implant-associated ALCL, and 33 women have died from it. Importantly, there have been no cases of ALCL-BIA noted in patients with smooth breast implants.

Board-Certified Beverly Hills Plastic Surgeon Dr. Joubin Gabbay Discusses the Recall

Dr. Gabbay discussed this recall on Instagram to provide the facts and reduce patients’ concerns about the recent recall. He acknowledged the significance of the recall, but assured patients their risk of getting ALCL is extremely low, and that most patients fully recover.

“In the vast majority of cases, ALCL is limited to the fluid collection around the implant, and the only treatment needed is to remove the implant, remove the fluid collection, and completely remove the implant capsule around the breast implant – that’s it,” Gabbay said in an Instagram story video. “If you already have textured breast implants…all you need to do is keep an eye on things.”

Do I Need to Have My Textured Breast Implants Removed?

No. Dr. Gabbay advises patients who have textured breast implants leave them in place, but he recommends ongoing consultations with the patient’s plastic surgeon to check for fluid accumulation surrounding the implant – one of the first symptoms of ALCL-BIA. Even if fluid is noted around the textured breast implant, Dr. Gabbay advises patients not to be alarmed. This is a rare, yet known side effect of any type of breast implant, and not only associated with ALCL-BIA . Further testing of the fluid surrounding the implant can help determine if ALCL – BIA is present or if the fluid collection is the result of something else.

Dr. Gabbay explained that patients who are concerned about the risk of ALCL associated with textured implants should consult with their own plastic surgeon. Follow-up consultations are important, he said, but it is almost always unnecessary to remove the textured implants.

What Are Other Risks of Breast Augmentation Surgery?

Risks associated with breast augmentation surgery are very low. Because it is an elective, cosmetic procedure, breast autmentation is performed and is so popular because the success of the procedure is so far greater than any associated risks. That said, any procedure has risks, and it is important to understand them whenever getting the procedure done.

The most common short- and long-term risks associated with breast augmentations that may lead patients to have their breast implants removed are:

• Infection
• Breast pain
• Nipple numbness
• Implant breakage or leakage
• The need for additional corrective surgery
• Patient dissatisfaction with the cosmetic result

Do you have questions about Allergan’s recent recall of Biocell textured breast implants and tissue expanders? Our team at Gabbay Plastic Surgery is happy to answer your questions. Reach out to us online, or call (310) 205-9500 to arrange a consultation.