2019 Recall of Textured Breast Implants

Aug 29, 2018 | Rhinoplasty

On July 24th 2019, Allergan announced a global recall of their BIOCELL textured breast implants and tissue expanders. This followed findings by the U.S. Food and Drug Administration (FDA) linking these implants to a rare form of immune system cancer known as implant-associated anaplastic large cell lymphoma (BIA-ALCL). An FDA analysis found that the risk of this lymphoma in patients with Allergan’s BIOCELL textured implants was about 6x the risk in patients with textured implants coming from other providers. 

Where are these devices used?

Breast implants are usually used during breast augmentation surgery, as well as breast reconstruction procedures following a lumpectomy or mastectomy. These implants may also be used during revision surgery that entails correcting unsatisfactory results of a prior augmentation. Tissue expanders – which were also mentioned in the FDA finding – are commonly used in the treatment of soft tissue deformities, underdeveloped breasts, as well as breast reconstruction after mastectomy. 

Implant Warranty 

In addition to the worldwide recall, Allergan created the BIOCELL® Replacement Warranty to help patients who wished to have their textured implants replaced with Allergan smooth implants. This warranty covers Allergan, Inamed and McGhan implants but does not include the surgical or facility costs involved in the implant replacement procedure. The warranty has been active since July 24th 2019 and will run till July 24th 2021. 

Symptoms of BIA-ALCL 

Following this recall, many women with textured implants have been concerned about their safety. According to the FDA, this lymphoma is limited to the fluid and scar tissue that forms near the implant. However, like with other cancers, it can spread to other parts of the body. Some of the main symptoms associated with BIA-ALCL include continuing swelling or pain in the area containing the breast implant. These symptoms are not immediate after breast augmentation and may, in fact, occur many years later. In some cases, a capsular contracture (lump) or collection of fluid may be noted. If you notice any of these symptoms, it’s important you call our office to schedule an in person consultation with  Dr. Vemula for further evaluation to see if you are a candidate for removal of your implants.

Most ALCL that is associated with implants can be treated through removal of the implant and the surrounding scar tissue in a procedure known as en bloc capsulectomy. Although not usually needed, additional treatments such as chemotherapy and radiotherapy may be necessary in some cases. 

What to Do

The FDA, at this time DOES NOT recommend removal of the above referenced and other types of implants for patients who are not experiencing any symptoms because the level of risk involved is very low. Some of the medical interventions that can be used to eliminate this risk altogether for breast augmentation patients include using alternative implants or autologous tissue. 

Because your health is our responsibility, Dr. Vemula has advised his patients to weigh their options and make an informed decision. Some of his asymptomatic patients choose to remove their textured implants just to secure their peace of mind knowing that they are not exposed to BIA-ALCL risk. If you have more questions or want to know more about your risk of ALCL, or the pros and cons of keeping your implants, get in touch with Dr. Vemula’s office at V Plastic Surgery.  Click here to schedule your consultation today.