FDA OKs Continued Use of Textured Breast Implants

Women considering breast augmentation at my Oregon plastic surgery practice occasionally ask if textured breast implants remain an option after reading recent reports linking those implants to various health concerns. The U.S. Food & Drug Administration (FDA) issued a statement in May saying that textured implants can still be used for breast enhancement, explaining that the scientific evidence doesn’t support taking them off the market.

The president of the International Society of Aesthetic Plastic Surgery, Dr. Dirk Richter, supported the FDA decision, which came after some studies showed a potential link between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is an extremely rare condition that is both detectable and curable.

What the FDA Says

In its announcement, the FDA concluded that women and providers must be adequately informed of the risk of BIA-ALCL and made aware that the risk is higher with the use of textured implants, which is still very low.

In an earlier blog post, I explained what women should know about BIA-ALCL and textured implants. The surgical techniques and processes I use during breast augmentation surgery—whether with smooth or textured implants—drastically reduce the chances of implant surfaces being contaminated with biofilm. This is crucial because BIA-ALCL is not breast cancer. Instead, it’s linked to rare bacterial contamination and has been found on a range of other medical devices.

Are Textured Implants Safe?

I believe textured implants, when clinically indicated, are safe provided these requisite steps are taken to minimize bacterial contamination of the implant. And the data I’ve compiled throughout my career demonstrates the effectiveness of these measures. Through 41 years of using breast implants, I’ve never had an infection in a primary breast augmentation procedure or an implant revision surgery.

In 2017, 7 other plastic surgeons and I published a study that included 21,650 patients who had textured implants whose cases all involved these 14 specific steps designed to minimize the risk of bacterial contamination. Based on the current risk, the expected number of BIA-ALCL cases was 14. The actual number of BIA-ALCL cases reported was zero. Patients were followed for 11 years on average.

In considering textured breast implants, it’s important to remember that the vast majority of women getting breast augmentation choose smooth implants. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S., according to the FDA. Teardrop-shaped or anatomic implants, are textured because they adhere better to the breast tissue than smooth-surfaced implants, reducing the chance that they’ll rotate. If shaped implants rotate, the breast can look unnatural.

I’m extremely proud of the track record I’ve created during my career for producing excellent results for breast augmentation patients at my Eugene practice. You can browse our gallery of before-and-after photos to see my actual breast augmentation patients results.

I use my expertise to help patients determine the correct implant for their breast augmentation procedures. You can contact us using the online form to request a consultation or call us at (541) 683-3234 to schedule an appointment.