Are Some Breast Implants Safer Than Others?

Complications requiring surgical removal or replacement of breast implants occur with approximately equal frequency across the various types of implants currently in use. This finding comes from a Dutch study recently published in JAMA Surgery, led by Juliët Vrolijk, MD, from the Department of Plastic and Reconstructive Surgery at Maastricht University Medical Center, Maastricht, the Netherlands.

The study also demonstrates that it is possible to combine data from different national registries to produce studies with sufficient statistical power, as noted by a team led by Katherine Anne Rodby, MD, a plastic surgeon from the University of North Carolina School of Medicine in Chapel Hill, North Carolina, in a commentary published in the same issue of JAMA Surgery.

Rodby and colleagues further suggest that the results from such pooled analyses are likely to be more generalizable than those from studies conducted at a single center.

Real-World Data

“Although breast implants have been used for decades to improve the quality of life, controversies remain regarding their overall safety and concerns about specific manufacturers, shapes, and surface textures,” the authors noted.

Despite their widespread use, no large-scale international studies have been conducted on the long-term revision incidence of different implant types. Because complications are rare, smaller studies have not provided sufficient evidence regarding the safety of different implant types. To address this gap, Vrolijk and colleagues conducted the first analysis of real-world data from two major national registries: The Australian Breast Device Registry and the Dutch Breast Implant Registry.

The study included all women in Australia and the Netherlands who received permanent breast implants between 2016 and 2021 for breast cancer, benign conditions requiring surgery, or elective breast augmentation. Saline-filled implants, which are rarely used for permanent implantation in these countries, were excluded.

In total, 21,115 reconstructive and 129,854 cosmetic breast implants were inserted in patients with median age of 47 (38-55) years and 31 (25-38) years, respectively.

The findings showed that the complication-related revision rates were 6.3% for reconstructive and 1.2% for cosmetic implants. The researchers further examined the revision rates on the basis of implant shape, surface texture, and fill material.

Anatomically shaped polyurethane shell and smooth shell silicone–filled implants had higher revision rates for malposition in the reconstructive group, whereas round textured shell silicone–filled implants were frequently revised for capsular contracture. Overall, the complication rates were minimal across the implant types.

Five-Year Revision Outcomes

The situation was somewhat different for cosmetic implants. Specifically, anatomical silicone implants with a polyurethane surface showed a significantly lower revision risk (with a hazard ratio of 0.38) compared with anatomical silicone implants with a textured surface. However, after 5 years, when Vrolijk and team examined the cumulative revision incidence, they found no significant differences between the different implant types in either group.

“This study showed that international datasets can be pooled to assess real-world incidence of breast implant revision, which is anticipated to generate a foundation on which future breast implant studies can be based,” the authors concluded.

Limitations

A limitation of the study, as noted by the authors, is that while the data were pooled, several factors that could influence the outcome of breast reconstruction or augmentation were not accounted for. Specifically, the team points to missing data on women’s body mass index and smoking status.

The findings are reassuring for plastic surgeons, suggesting that “implant type choice can be made based on clinical indications, aesthetic goals and patient preferences.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.