Breaking News: Ideal Implant Abruptly Ceases Operations Causing Unfortunate Implications for Patients
A promise that was marketed by the Ideal Implant manufacturer to breast augmentation patients is now broken and patients who paid for these warranties may now be responsible for future surgery.
On May 30, 2023, Ideal Implant Incorporated announced it was ceasing operations, which raises significant concerns about warranty and replacement options for patients. New Beauty reported in a recent article, “According to an email sent out from the company, the decision to liquidate was a result of their inability to secure sufficient investment and generate a sustainable profit. Consequently, patients who currently have these breast implants will no longer have a valid warranty on the devices. The implant offered a device warranty that covered rupture and capsular contracture for a period of 10 years from the date of surgery for primary augmentations and 20 years for primary reconstructions.”
At this time, there is no recall or safety alert issued on Ideal Implants and there has been no new recommendation made for patients with Ideal Implants. It is important to note that on May 14, 2020, the FDA issued a warning letter to Ideal Implant Incorporated. According to Madris Kinard of Device Events, “This is interesting because this became a criminal investigation since they weren’t reporting adverse events to the FDA.”
“Buyer Beware. Let this be a reminder to all patients and consumers to be cautious. New does not always mean safer or better, sometimes it means unproven. I have deep empathy for patients with these implants.” says Maria Gmitro, BISA’s president.
We will share more updates and provide resources as more information is revealed. If you have Ideal Implants, we want to hear from you. Patients with the Ideal Implants, or any implanted medical device that have experienced problems, can and should self-report directly to the FDA MedWatch Program.
Resources:
New Beauty: Ideal Implant Ceases Operations, Leaving Breast Augmentation Patients in Limbo
FDA: May 14, 2020 Warning Letter Ideal Implant Incorporated
FDA: What to Know about Breast Implants
Breast Implant Safety Alliance (BISA) is a nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, plastic surgeons, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization and is not funded by implant manufacturers.
Contact: Maria Gmitro, President | 843.501.6873 | maria@bisanonprofit.org