We are reaching out to all our patients to provide you with information about the voluntary recall by Allergan of their BioCell-textured surface breast implants from the worldwide market on July 24, 2019. You may have already read or heard about this implant withdrawal by Allergan and we want to ensure you have the most up-to-date and accurate information available. In addition to this blog post, we have emailed all of our patients about this important topic.
Key points about the Allergan BioCell-textured surface breast implant withdrawal:
- This withdrawal means that Allergan will no longer sell or distribute these BioCell-textured breast implants and tissue expanders.
- This breast implant withdrawal DOES NOT apply to the smooth-surfaced breast implants from any of the breast implant manufacturers including Allergan worldwide. It is estimated that 85% of all breast implants used in the United States are smooth-surfaced implants.
- Allergan and the Food and Drug Administration (FDA) made this decision based upon new information indicating a higher risk for patients with these BioCell-textured surface implants to develop a rare type of cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL than previously thought.
- The risk for developing BIA-ALCL in patients with the Allergan BioCell-textured surface implants is estimated to be as high as 1 in 3200 though the exact risk is thought to be lower. To date, there have been less than 800 cases of BIA-ALCL identified worldwide.
- Patients who already have BioCell-textured surface breast implants or tissue expanders placed for breast augmentation or breast reconstruction are not recommended to have their implants removed at this time. This recommendation is based on the current data available which indicates the very low risk for developing BIA-ALCL when compared to the risks for a second surgery to remove and replace your breast implants.
- Patients who have breast implants with the BioCell-textured surface who are asymptomatic are advised to be monitored by their plastic surgeons on a regular basis.
- BIA-ALCL is not breast cancer but a highly treatable type of lymphoma that develops in the space between the breast implant and the capsule that surrounds the breast implant.
The most common symptoms for BIA-ALCL are:
- Sudden, unilateral swelling of one breast-the most frequent symptom in most patients
- A lump or swelling in the breast or under the arm
- Increased pain in one breast
- A rash on and around the breast is the least common symptom
Patients without any symptoms are very unlikely to have developed BIA-ALCL.
Treatment for BIA-ALCL
For patients who have any of the symptoms listed above, the first step is a consultation with a plastic surgeon. One of our plastic surgeons will perform an examination and, if necessary, order further testing.
For most patients who are diagnosed with BIA-ALCL, treatment involves removing the breast implants and the surrounding capsule, the scar tissue formed by your body around the implant. This treatment is curative for most patients. Rarely do patients require other additional treatments such as chemotherapy and/or radiation treatment.
If you have any questions about the Allergan BioCell-textured implant withdrawal, please call us at 636-530-6161. We are here to help answer your questions and address your concerns. You may also want to read Allergan’s alert regarding the BioCell-textured implants.