On July 24, 2019, Allergan withdrew all BioCell textured breast implants from the market.
Last month, Allergan® recalled every textured breast implant they sold in the US. Read my previous post for details about the BioCell® Textured Breast Implants Recall.
This month, Allergan® has updated their warranty for the affected BioCell® Textured Breast Implants. The following information comes directly from Allergan®, and is correct at the time of publication. As with any warranty, be sure to check with Allergan® directly if you have questions about their products.
What Implants Are Covered?
The BioCell® Replacement Warranty covers all BioCell® textured implants that were manufactured under the brands McGhan®, Inamed®, Allergan® or Natrelle®. Both saline and silicone gel-filled textured implants are covered. This coverage will be available through July 24, 2021. Please note that Natrelle® smooth breast implants are not subject to this withdrawal.
What Are The Replacement Options?
The FDA web site has up-to-date breast implant and BIA-ALCL information.
The FDA recommends not to remove devices if you do not have symptoms. However, if you and your plastic surgeon decide that replacing your device(s) is in your best interest, you can choose any Allergan® smooth breast implant(s) as a replacement on or before July 24, 2021.
You should bring your current patient ID card or any other information available about your implants with you to your appointment. You and your plastic surgeon will decide on the best size and style as a replacement option for you. Your plastic surgeon will request your replacement implants from Allergan® on your behalf.
Are Surgery Fees Covered?
No. As part of this program, Allergan® will not provide surgical fee assistance. This decision is aligned with the FDA’s recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of BIA-ALCL.
What If I DO NOT Explant My Textured Implants?
If you choose not to explant your BioCell® textured devices, you will continue to be covered under the Natrelle® ConfidencePlus® Warranty, which includes comprehensive coverage including rupture, capsular contracture and late seroma. More information about the Natrelle® ConfidencePlus® Warranty can be found at Allergan.com.
How Do I Know If My Implants Are Textured?
Allergan Smooth and Textured Breast Implants
Most breast implants used world-wide are Smooth Breast Implants. All teardrop shaped implants are textured, so if you have teardrop shaped breast implants, you have textured implants. For Allergan®, these are called style-410. Some round implants are textured. You will need the catalogue number for your breast implants to know if they are textured.
Please visit Allergan.com to understand how to read your product ID card. If you don’t have a card, or would like to speak to someone at Allergan, please contact Allergan Medical Information at 1-800-678-1605, option #2, or email IR-Medcom@allergan.com.
How Do I Learn More About BIA-ALCL?
I am constantly updating my blog with new information about BIA-ALCL and other Plastic Surgery News. So keep tuned to the San Francisco Plastic Surgery Blog for more information. Additional reading is available on the FDA Website.
Textured Implant Removal or Exchange Consultations
If you are concerned about your breast implants and are considering changing size or style, be sure to consult with a Board Certified Plastic Surgeon near you. In the San Francisco Bay Area, call our Walnut Creek Plastic Surgery Center at (925) 943-6353 to schedule your appointment.