Breast implants are medical devices used for both cosmetic augmentation and reconstructive procedures following mastectomy. All implants consist of a silicone shell filled with either saline or silicone gel. They are categorized by the texture of their outer surface: smooth or textured. Textured implants have recently become the focus of intense medical and regulatory review due to their association with a specific health condition.
The Distinctive Surface of Textured Implants
The surface of a breast implant shell is intentionally roughened to distinguish it from a smooth implant. Texturing is classified based on its microscopic characteristics, typically divided into micro-texture and macro-texture, determined by the size and depth of the pores on the shell.
Micro-textured implants feature a slightly rough surface, barely discernible to the touch, with pores measured in the micrometer range. Macro-textured implants present a much rougher, more abrasive surface, often described as feeling similar to sandpaper. Manufacturers achieve this roughness through methods like salt-loss imprinting or using polyurethane coatings, which significantly increases the device’s surface area.
Initial Purpose for Using Texture
The design intention for textured surfaces was to improve long-term outcomes after implantation. A primary complication of breast augmentation is capsular contracture, the formation of a hardened, tight layer of scar tissue around the implant. The textured surface was engineered to encourage surrounding breast tissue to adhere to the implant shell.
This adherence, or tissue ingrowth, was hypothesized to disrupt the continuous scar tissue layer that forms around smooth implants, thereby reducing the rate of capsular contracture. Anatomical or “teardrop-shaped” implants often rely on texture to maintain their correct orientation. By anchoring the implant to the chest wall, texturing was intended to prevent the device from rotating within the breast pocket, preserving the desired cosmetic shape.
Breast Implant-Associated Anaplastic Large Cell Lymphoma
The most significant risk associated with textured implants is the development of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This condition is not breast cancer, but rather a rare type of T-cell non-Hodgkin lymphoma. It develops in the fluid or scar capsule surrounding the implant, originating from immune system cells exposed to the implant surface.
The mechanism linking the textured surface to BIA-ALCL involves chronic inflammation and bacterial accumulation. The rough surface provides an ideal environment for bacteria to form a protective layer called a biofilm. This persistent bacterial presence may trigger a continuous immune response, eventually leading to the malignant transformation of T-cells near the implant.
Symptoms of BIA-ALCL often appear years after surgery, with the average time to diagnosis ranging from seven to ten years. The most common symptom is a sudden, noticeable swelling of the breast caused by a late-onset fluid collection, or seroma, around the implant. Other signs include pain, a lump in the breast or armpit, or a change in the breast’s shape.
Diagnosis typically begins with imaging, such as an ultrasound, to confirm a fluid collection around the implant. If fluid is detected, a sample must be aspirated and tested for malignant T-cells, specifically looking for the CD30 marker. The lifetime risk of developing BIA-ALCL is low, but it is significantly elevated in patients with highly textured devices compared to those with smooth implants, which have no confirmed cases.
Global Regulatory Actions and Product Availability
Concerns over BIA-ALCL led to significant regulatory actions worldwide, particularly concerning macro-textured devices. In July 2019, the U.S. Food and Drug Administration (FDA) requested that Allergan initiate a voluntary global recall of its BIOCELL textured breast implants and tissue expanders. This decision was based on data indicating that the BIA-ALCL risk was approximately six times higher with the BIOCELL macro-texture compared to other textured implants available in the U.S.
The FDA issued safety communications to inform patients and providers about the elevated risk and the recall, which affected numerous product lines. Similar withdrawals and restrictions occurred in other countries, including Canada, France, and Australia, effectively removing the highest-risk implants from the global market. While some micro-textured implants remain available, the use of textured surfaces has declined sharply in favor of smooth devices due to the clear association with BIA-ALCL.
Ongoing Monitoring and Treatment Protocols
For individuals who currently have textured breast implants, medical professionals do not recommend prophylactic removal if the patient is asymptomatic. The focus is placed on diligent self-monitoring and awareness of potential symptoms. Routine self-exams are encouraged, and any new or persistent changes, such as unexpected swelling, fluid accumulation, or a palpable mass, should be promptly evaluated by a physician.
If symptoms suggestive of BIA-ALCL arise, the diagnostic workup involves specialized imaging like ultrasound to visualize the implant and the surrounding capsule. If BIA-ALCL is confirmed, the standard and most effective treatment is surgical. This typically involves the complete removal of the implant and the entire fibrous capsule in an operation known as a total capsulectomy.
For the majority of cases confined to the fluid or the capsule, surgery alone is curative, resulting in an excellent prognosis. In rare instances where the cancer has spread beyond the capsule, additional treatment with chemotherapy or radiation may be necessary. Following successful treatment, patients are advised to undergo clinical and imaging surveillance every six months for the first two years to monitor for recurrence.