Introduction: Plastic surgeons face an elevated risk of involvement in malpractice cases compared to other specialties. Fear of malpractice litigation may influence surgeon behavior and decision-making, potentially contributing to heightened healthcare costs. This study aimed to determine the prevalence and characteristics of malpractice litigation associated with breast implants.

Methods: A comprehensive search involving the Westlaw Campus Research legal database was conducted to identify all cases involving malpractice complaints and breast implants. All available malpractice cases involving breast implants/prostheses from the earliest available documentation to February 1st, 2024 were retrieved and screened. Cases were included if a patient initiated a medical malpractice or negligence case after undergoing breast augmentation or reconstruction involving implants. Class action suits and cases with limited information were excluded. The extracted data from the cases included the date of the earliest available documentation, initiation location, patient gender, patient vital status, indication for implant(s), involved medical specialties, types of alleged negligence, diagnostic and postoperative complaints, autoimmune-related complaints, involvement of capsular contracture along with subsequent open/closed capsulectomy, and case outcomes. Descriptive statistics were calculated.

Results: 650 cases were identified after the exclusion of duplicates; 128 cases met the inclusion criteria. Cases were most commonly initiated in the state of Texas (N=17, 13.3%) and New York (N=13, 10.2%) and documentation was dated 1967-2023. All of the cases involved female patients; one woman identified as transgender. Three (2.3%) patients were deceased at the time of the trial. Plastic surgeons were most commonly the defendant(s) (N=113, 88.3%). Malpractice claims were most frequently associated with the initial breast implant placement (N=89, 69.5%), rather than a breast implant removal with or without replacement (N=26, 20.3%). Negligent technique, improper informed consent, and poor postoperative management were cited as reasons for alleged malpractice in 90 (70.3%), 65 (50.8%), and 64 (50.0%) of the cases, respectively. Patients alleged that they did not receive the type of implant (saline vs. silicone) or size of implant they requested in 7 (5.5%) and 5 (3.9%) of the cases, respectively. 20 (15.6%) of the cases were ruled in favor of the plaintiff prior to appeal; 5 cases involved implant-based reconstruction, while 15 cases involved cosmetic implant-based augmentation. Eight patients claimed that their implants led to the development of cancer, autoimmune conditions, or other health conditions; only one case led to a ruling in favor of the plaintiff in 2001.

Conclusion: These findings underscore the importance of comprehensive preoperative education, specifically addressing implant types, demystifying information about breast implant-associated illness, and setting realistic goals surrounding implant sizing. Surgeons should maintain heightened vigilance when patients present with abnormal postoperative changes in the breast tissue. Thorough work-up and placement of appropriate referrals should be conducted to prevent delays in potential breast cancer diagnoses.