FDA Panel Seeks More Data on Filler Use in Decolletage Area

Medscape

a day ago

A FDA advisory panel recommended that manufacturers of dermal fillers collect more information on use in the decolletage area of the body and said that some patients might be at higher risk of complications from injections because of the proximity to breast tissue.
The FDA has not approved dermal fillers for use in the decolletage — a body area that advisory panel members said was not well-defined. It is generally considered the triangular area that runs from the neck and clavicle area to in between the breasts.
Agency officials and committee members noted that fillers are increasingly being used off-label to improve skin texture, crepiness, skin thickness, fine lines, and wrinkles in the decolletage. The most common fillers used in the neck and decolletage are made up of hyaluronic acid (HA), calcium hydroxylapatite (CaHA), or poly-L-lactic acid (PLLA), according to the American Academy of Dermatology Association (AADA).
At a meeting on August 13, the FDA's General and Plastic Surgery Devices Panel was asked to review safety concerns, in anticipation that manufacturers will soon seek FDA approval of fillers for use in the decolletage area and need guidance on trial design and post-marketing studies. The agency raised the possibility that fillers could migrate from the injection site or form nodules and/or granulomas and interfere with mammograms, cause false positive readings on breast imaging or clinical exams, or impact breast feeding and lymphatic drainage.
The committee — made up of dermatologists, plastic surgeons, oncologists, and radiologists — did not formally vote. The panel members agreed that patients who are breastfeeding or pregnant should be excluded from receiving injections because of the unknowns. Individuals with darker skin types or known wound-healing issues — both of whom might easily form keloids or nodules — or those with a history of radiotherapy, lymphoma, or other blood cancers were also seen as potentially higher risk populations, said panel chairman Hobart Harris, MD, MPH, the J. Engelbert Dunphy endowed chair in surgery at the University of California, San Francisco.
Sandra R. Shuffett, MD, a breast imaging specialist in Lexington, Kentucky, and temporary panel member, said she was concerned that fillers could obscure tumors on breast imaging tests. 'My focus is to find a cancer as small as possible,' she said, adding that an unseen tumor could quickly grow larger, necessitating more serious treatment.
The FDA has not received reports of problems with breast feeding or imaging but a post-approval study of Radiesse (CaHA) found that it obscured bone visualization. There have also been reports of lymph node enlargement near dermal filler injection sites.
FDA reviewer Sung Yoon, MD, said at the meeting that the agency is 'not aware of specific reports where breast cancer was missed' because of dermal filler but noted that off-label use might mean less reporting of adverse events.
Yoon told the panel that an analysis of the FDA's Medical Device Reporting database found 20 reports of serious injury events associated with the use of dermal fillers in the decolletage area since 2007 out of 186 reports related to unapproved upper body use. It is not possible to know how many decolletage procedures have been performed, she said. The FDA reported that an estimated 6.2 million dermal filler procedures were performed in 2024.
Radiesse manufacturer, Merz Aesthetics, told the panel that, between 2018 and 2025, it received 44 reports of potential adverse events in the decolletage area, with none reporting migration of material or radiological interference. Radiesse is approved for decolletage wrinkles in the European Union and Canada.
Social media may be fueling more use of fillers in the decolletage, especially among those taking GLP-1 receptor agonists for weight loss who are seeking 'to improve the skin rippling in the chest,' said Karol A. Gutowski, MD, a Chicago-based plastic surgeon who spoke to the committee.
Representatives from dermatology and plastic surgery organizations said they had crafted guidelines for safe use of fillers in the decolletage but warned that filler use was often unregulated.
'Filler adverse events are likely under reported, and they're increasing in frequency as the popularity of injectable fillers increases,' said M. Laurin Council, MD, director of dermatologic surgery at Washington University School of Medicine, St. Louis, who spoke to the panel on behalf of the American Society for Dermatologic Surgery.
Many panelists suggested women undergo baseline breast imaging before receiving filler in the decolletage area and collecting more data — such as on the volume of filler used during procedures — and added that perhaps a registry should be created. But some were skeptical.
'Probably 75% of these injections are done by non-medical people,' such as attendants at medical spas or storefront wellness centers, said panelist Alan Matarasso, MD, a New York City-based plastic surgeon and past president of the American Society of Plastic Surgeons. Matarasso said that manufacturers should be responsible for tracking their products, not clinicians.
'When these things are being done in strip malls and other places, we're not going to get the data that we need, because people are not going to cooperate with this,' said Gutowski.
There is no approved method of removing dermal fillers. That gave some panel members pause. But dermatologists and plastic surgeons said that HA-based fillers could be dissolved with hyaluronidase. Even so, CaHA and PLLA fillers can't be dissolved and 'must break down naturally over time,' said Natalie Curcio, MD, MPH, a Nashville-based dermatologist who spoke to the panel on behalf of the AADA.
Temporary committee member Karla V. Ballman, PhD, professor of biostatistics at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota, said that patients should be informed, perhaps via wording on a product label that 'at the current time, there is no approved method of removal' of a filler.
The FDA has periodically examined dermal filler safety. In July 2023, the agency updated its informational webpage to describe a new risk of delayed-onset inflammation near treatment sites that had been reported to occur following viral or bacterial illnesses or infections, vaccinations, or dental procedures. The webpage also lists common reactions such as bruising, redness, swelling, and pain.
At the panel meeting, consumer advocate Diana Zuckerman, PhD, president of the National Center for Health Research, said that listing adverse events was not enough. 'Risks should be quantified with meaningful statistical data on the short term and long term risks,' said Zuckerman, who spoke during the open public hearing. 'FDA should require well designed and full clinical trials so that patients have the information they need to make informed decisions,' she said.
'FDA really appreciates the thoughtful discussion questions and recommendations that have been provided today, and we will certainly take all of these comments into consideration as we move forward,' said Cynthia Chang, PhD, an acting division director within the agency's Center for Devices and Radiological Health.