New Reports About Breast Implant Risks

Orange County plastic surgeons Dr. Larry Nichter and Dr. Jed Horowitz of Pacific Center for Plastic Surgery perform hundreds of breast surgeries each year, including first-time augmentation, breast lifts, breast reduction, and revision breast surgery. Both doctors are committed to educating their patients and prospective patients about topics relating to the plastic surgery industry. At times, the doctors are alerted about important industry news, advancements in surgical techniques, and the development of new products, which they feel is important to pass along.

New information has been released by the FDA claiming women with textured breast implants (e.g. all shaped/anatomic implants are shaped) have a small but significant risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, and simple removal of the implant and surrounding capsule (capsulectomy) is curative but in some cases, it can spread to the nearby lymph nodes or throughout the body.

Precise risks are difficult to determine due to the lack of information about how many patients have received breast implants in the US and worldwide. At this time, most data suggest that ALCL occurs almost exclusively following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Since it appears ALCL develops more frequently with textured implants, Dr. Horowitz and Dr. Nichter are advising women about to educate themselves about this risk prior to selecting this type of implant.  For women who currently have textured breast implants, both doctors agree there is no need to change their routine medical care and follow-up unless they are experiencing unexplained medical issues, changes in the way their breasts look or feel, if the implants are ten or more years old, or wish to exchange them for peace of mind.

For women with textured implants and have concerns regarding this information, please read more here: https://www.plasticsurgery.org/documents/Health-Policy/ALCL/ALCL-Brochure-Trifold.pdf. Again, current information shows the risk to be small and related only to textured implants.

At the American Society of Aesthetic Plastic Surgery, Dr. Nichter presented the first release of data of the 7 year FDA IDEAL® Structured Implant data. It was demonstrated there is an increased risk of capsular contractures and rupture rates for all other silicone and saline implants currently available in the United States. Recent concerns with silicone implants have also been noted in a recent article in the Annals of Plastic Surgery and the FDA has responded by saying they plan to convene a public meeting of medical advisers in 2019 to discuss new science on breast implant safety, including an analysis that claims some rare health problems might be more common with silicone gel implants.

Approximately 400,000 women each year in the United States opt for breast implants with the vast majority selecting silicone implants because of the reputation that they look and feel more like natural breasts. Even with the FDA warning that breast implants are not lifetime devices, have issued guidelines recommending an MRI scan at 3 years post-implant and every 2 years after that. It is estimated that more than 150,000 women are unaware they are living with ruptured silicone implants. Not only are silent ruptures a concern, but aging implants can also cause wrinkling, capsular contracture causing hardening of the implant, pain, and swelling. In contrast, the IDEAL® Structured implant is a saline implant that is made to feel like silicone without the worry of silent rupture, or need for MRI follow-up, or replacement until there is a leak as the content is just sterile saline. Rather than a MRI for monitoring, just looking in the mirror will tell if there is a problem. This will result in fewer surgeries for each patient over their lifetime.

Read more in this recent press release.