Breaking News About Textured Breast Implants: FDA Will Not Ban Sales

June 12, 2019

Every year, around 400,000 women in the US receive breast implants. Some women get
implants to feel more confident and for others it’s part of rebuilding the breast after various
accidents or illnesses. Women who have had the procedure report feeling an improved body
image and an increased self-esteem. Recently, the silicone devices used for breast implant
procedures have been getting a closer look from the Food and Drug Administration (FDA). In
response to growing public interest in the potential risks associated with breast implants,
FDA regulatory authorities have released a statement.

The FDA assessment of breast implant devices has been ongoing for several years. This
specific reassessment concerned the use and availability of textured breast implants in
plastic surgery procedures. Textured implant devices, as opposed to smooth implant
devices, make up 10% or less of the implants sold in the US. Earlier this month, the FDA
notified the public of its decision not to take regulatory action at this time to limit the
availability of textured breast implants, stating there was not sufficient evidence to support
banning the implant device.

The FDA regulatory reassessment was performed in response to a possible connection
between textured breast implants and the development of breast implant-associated
anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is a T-cell lymphoma causing cancerous
cells in the immune system that can develop in tissue following a breast implant procedure.
Most of the women diagnosed with BIA-ALCL had textured breast implants. The most
common symptom related BIA-ALCL is fluid buildup around the implant. This usually occurs
years after implant placement.

While the FDA assessment did conclude there are potential risks associated with textured
implants, these risks are low and the cause of the association with BIA-ALCL needs to be
investigated further. In the US, 457 women have been diagnosed with BIA-ALCL according to
the FDA, but this number is very small compared to the number of women who receive
breast implants. The FDA study also couldn’t make a solid connection between these breast
implants and other ailments like chronic fatigue, joint and muscle pain, and cognitive
impairment.

The comprehensive examination of this connection included post-approval study data,
scientific literature, medical device reports, and a public hearing. The hearing allowed all
potential stakeholders the chance to submit their concerns or support concerning this topic.
After a review of this data, the FDA has stated, “At this time, the FDA does not believe that,
on the basis of all available data and information, the device meets the banning standard set
forth in the Federal Food, Drug and Cosmetic Act.”

In order to acknowledge the large response exhibited by the public for stronger warning
statements and stricter manufacturer monitoring, the FDA is considering how to best inform
patients of potential risks associated with breast implant devices. In order to address
concerns, the FDA is considering a boxed warning and patient consultation checklist
describing any potential harms associated with breast implant procedures. The FDA hopes
this will ensure that patients have all necessary information to make informed medical
decisions before receiving plastic surgery. The agency is also now requiring breast implant
manufacturers to file individual medical device reports for any reported issues concerning
the implants.

Dr. Teotia respects her patients’ wishes as they decide which type of implant is right for
them. Every woman has different aesthetic goals and individual needs. Dr. Teotia and her
team are committed to providing quality care and optimal results for every client. Staying on
top of the latest news in plastic surgery allows Dr. Teotia and her team to empower clients with
the knowledge needed to make informed medical choices.