Breast implants are medical devices subject to regulatory oversight and occasional recalls, though such actions are rare. A recall is a voluntary or requested action by a regulatory body, like the U.S. Food and Drug Administration (FDA), to remove a product from the market due to safety concerns. This action is intended to protect public health by addressing a potential risk associated with the device. When safety data indicates a product may pose a disproportionate risk, the regulatory process mandates a recall to prevent further use.
Specific Implants That Have Been Recalled
The most significant and recent worldwide regulatory action involved textured breast implants manufactured by Allergan. This recall, initiated in July 2019 at the request of the FDA, focused specifically on the company’s BIOCELL textured products. The recall included a wide range of both silicone-filled and saline-filled implants that utilized the unique BIOCELL texturing method.
The specific product lines affected were the Natrelle Saline-Filled, Natrelle Silicone-Filled, and Natrelle Inspira Silicone-Filled breast implants, along with the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also extended to tissue expanders that shared the same textured surface, such as the Natrelle 133 Plus Tissue Expander. This was a worldwide recall, meaning the manufacturer stopped the sale and distribution of these macro-textured models globally.
The recall did not affect Allergan’s smooth-surfaced implants or textured implants made by other manufacturers, such as Mentor or Sientra. The regulatory focus was narrowly placed on the specific macro-textured surface of the BIOCELL line. The FDA based its request on a strong link between this particular surface texture and a rare form of cancer.
Safety Concerns Driving Regulatory Action
The primary reason for the regulatory action was the established link between the textured implant surface and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is a rare type of non-Hodgkin’s lymphoma that develops in the fluid or scar tissue surrounding the implant, not the breast tissue itself. While often treatable when detected early, the condition can be life-threatening.
Data analyzed by the FDA indicated that the risk of BIA-ALCL was significantly higher with the Allergan BIOCELL textured implants compared to other textured and smooth implants. Specifically, the risk was found to be approximately six times greater with the BIOCELL products than with textured implants from other manufacturers. This heightened risk was the direct trigger for the worldwide recall request.
The theory suggests that the rough, macro-textured surface of the recalled implants may cause chronic inflammation or irritation in the surrounding tissue capsule. This long-term irritation may eventually lead to the development of BIA-ALCL, typically several years after placement. The recall served as a precautionary measure to prevent new patient exposure to the devices with the highest associated risk.
Navigating Patient Steps After a Recall
Patients who have had breast augmentation or reconstruction should first determine their implant type, especially if the procedure involved a textured device. The most reliable way to confirm the type, model, and manufacturer is by obtaining a copy of the operative report from the original surgeon or hospital. Most patients are also given an implant identification card immediately following their procedure.
If an individual determines they have one of the recalled BIOCELL textured implants, regulatory agencies do not recommend prophylactic removal if the patient is asymptomatic. The risk of surgical complications from removal is generally considered higher than the low absolute risk of developing BIA-ALCL. Current guidance emphasizes awareness and monitoring rather than immediate surgery.
Individuals should monitor for symptoms of BIA-ALCL, which commonly include sudden or persistent swelling, pain, or a lump near the implant. If these symptoms occur, it is important to promptly consult with a board-certified plastic surgeon or healthcare provider. Diagnosis typically involves imaging and fluid testing from around the implant, especially if fluid accumulation is present.
Regarding costs, some manufacturers and insurance providers may offer coverage for the explantation and replacement of recalled implants, especially if a patient develops BIA-ALCL. However, routine removal for asymptomatic patients may not be covered by insurance. Patients should discuss potential out-of-pocket costs with their surgeon and insurance company before making decisions. Continuing regular follow-up with a medical professional remains the most appropriate course of action for monitoring implant health.