FDA Public Advisory Committee Meeting Covering Breast implants
On March 25 and 26, 2019, the U.S. Food and Drug Administration (FDA) conducted a Public Advisory Committee meeting to discuss the risks and benefits of breast implants used for breast augmentation and reconstruction.
Breast implants have been studied extensively for decades, and this is the eighth advisory committee meeting on breast implants since 1991, according to an agency timeline.
FDA Topics of Discussion
Some of the major topics of discussion included breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the use of registries for breast implant surveillance, MRI screening for silent rupture of silicone gel-filled breast implants, the use of real-world data and patient perspectives in regulatory decision making, and finally, best practices for informed consent discussions between patients and clinicians.
Along with agency officials, experts, and patients, Dr. Bajaj was able to speak to the panel about her experience with her patients and personal experience when it comes to breast implants. Dr. Bajaj’s position is to advocate for informed patient choice and yearly follow-up appointments with your plastic surgeon.
Watch the webcast video of Dr. Bajaj speaking at the meeting: 3:21:33- 3:22:23
Advocating for Patient Choice
“Although I am a plastic surgeon, I’ve never been an advocate for breast implants, rather I am an advocate for my patients and for patient choice,” Dr. Bajaj says.
Reflecting on her personal experience with breast implants, she emphasizes the importance of choice. “I chose to get implants because I felt self-conscious about my breast development. I was tired of wearing padded bras and clothes that didn’t fit,” Dr. Bajaj says. “So, I got breast implants and I’ve never regretted this decision and I feel very confident and happy with my decision.”
“Both my cosmetic and reconstructive patients have similar comments that they are happy with their implants and do not regret their choices,” she says.
In fact, breast augmentation was the most popular cosmetic surgical procedure performed in 2018, according to the American Society of Plastic Surgeons (ASPS). The ASPS released new data earlier this month that revealed 313,735 breast augmentation procedures were performed in 2018, which was a 4% jump from the 300,378 procedures conducted in 2017.
Personal Experience with Breast Implant Outcomes
“Numerous studies and my personal experience in my own patients have shown me that most patients have a high satisfaction rate and an improved quality of life and self-esteem,” Dr. Bajaj says.
However, every patient is different. Dr. Bajaj references her own sister’s experiences with breast implants.
“One sister was concerned for her health and switched from silicone to saline because she was concerned about silent rupture,” she says. “The other sister had hers removed because her body had changed.”
Many plastic surgeons in the meeting reported patient satisfaction with breast implants but agreed that patients should have all up-to-date information to make a choice when considering the procedure.
Understanding the Benefits and Risks of Breast Implants
“Every surgical procedure, including the placement of breast implants, has risks and benefits,” Dr. Bajaj says. “Some patients will benefit, and others may not.”
Therefore, it is important that physicians listen to their patients, educate them about the risks and benefits of any surgical procedure, and help them make the decisions that are best suited for them as individuals.
Encouraging Informed Patient Decisions and Follow-Up Appointments
Another point of discussion during the advisory meeting was the importance of a national registry for breast implants. The Plastic Surgery Foundation has collaborated with the FDA and breast implant device manufacturers to develop the National Breast Implant Registry (NBIR) to strengthen the surveillance infrastructure for current and future breast implant devices.
In addition to having a database, most experts are encouraging patients to follow-up on an annual basis after their breast implant procedure to help monitor for any post-surgical complications.
“We need the data and information to provide our patients with the best and most up-to-date information available,” Dr. Bajaj says. “We need to educate our patients about the importance of annual follow-ups with their plastic surgeons so that we can monitor for these adverse events.”
“Rather than taking away choices for women, we should arm them with information, so they can make the right decision for themselves.”
We understand that the decision to have plastic or reconstructive breast surgery is very personal. This is why our team strives to deliver complete and honest assessments before surgery and provide any information available to help you make the best decision for you and your body.