Stop Text(ur)ing Me!
In December of 2018, Allergan was prohibited from selling its popular Textured Breast Implants in Europe. This action was undertaken by denying Allergan a renewal of Safety Certificate (CE), which is required of all medical devices sold in Europe.
Why did European regulatory agencies deny Allergan Textured Breast Implants the vital certificates of safety, and what are Textured Breast Implants?
A Textured-Shell Breast Implant is simply one in which the surface has been roughened or texturized. This practice was introduced in the third-generation of breast implants (first-generation implants were smooth whereas the second generation implants had a polyurethane coating). The purpose of texturing breast implants is to promote improved adherence of the implant to surrounding tissues and decrease Capsular Contracture. Furthermore, it is believed that a textured surface results in improvements in positioning of the implant within the pocket. In the United States, most breast implants used are Smooth-Shell implants. In the rest of the world, 90% of breast implants used are textured. This may be in part to the continued availability of polyurethane coating in Europe — a method of texturing not available in the US.
Allergan is the only manufacturer of textured implants denied a Safety certificate. Both Mentor and Sientra continue to sell their textured implants in Europe. The Allergan shell texture differs from other manufacturers in that it has a Macro-texture. Macro-texturing is associated with improved tissue ingrowth or incorporation. The other manufacturers use Micro-texturing or a combination of micro/macro texturing.
The failure of Allergan to achieve the European Safety Certificates for its textured breast implants follows the recommendation that only smooth-shell breast implants be used instead of textured due to the association with BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma). For more information on BIA-ALCL, please see Blog No. 11.
The vast majority of BIA-ALCL cases have occurred in textured-breast implants and over 70% of these were identified in Allergan products. While there are undoubtedly other factors involved (patient pre-dispositions, bacterial contamination etc), it is the association of BIA-ALCL with Allergan implants that eventually prompted the European Safety Certificate to be voided.
In light of the withdrawal of safety certificates for textured breast implants, the British Association of Plastic Surgeons has recommended that Plastic Surgeons not use textured breast implants. No such recommendations or restrictions have been placed in the US.
In the United States, the FDA has ruled that all breast implants continue to be safe and no further screening is necessary for women with breast implants.
At Reddy Aesthetics, I have been using smooth-shell breast implants almost exclusively since the early reports on BIA-ALCL began to emerge. The benefits of smooth shell silicone implants compared to textured implants are as follows: a more natural feel to the augmented breast; smaller incisions for breast augmnentation; and less wrinkling with properly filled implants.
It is important to understand the differences between textured and smooth surfaced implants when choosing implants with your Board Certified Plastic Surgeon. If you are concerned with your current implants or would simply like to learn more about textured or smooth shelled implants, please contact us at (404)-481-5089 or visit us at reddyai.com. We will be pleased to direct you to the appropriate educational resources or answer your questions.
Long-Term Safety of Textured and Smooth Breast Implants. Calobrace et al. Aesthetic Surgery Journal Sept 2017, 1-11.
Dr. Reddy is a Board Certified Plastic Surgeon with additional training in Breast Reconstruction.
P. Pravin Reddy, MD is a Board Certified Plastic & Reconstructive Surgeon and a member of the American Society of Plastic Surgeons.