Ideal Implant Recalls Structured Saline Breast Implants Due to Deflation
Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the defect involves a structural failure (deflation) of a medical device, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Ideal Implant Incorporated is recalling 1,704 IDEAL IMPLANT Structured Breast Implants. The affected products are saline breast implants in sizes ranging from 210cc to 675cc. The recall covers serial numbers between 0100292 and 0102777.
The recall was initiated because the implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. This defect affects the structural integrity of the device.
The affected implants were distributed worldwide, including nationwide in the United States and in Canada. Patients who have received these implants should contact their healthcare provider for evaluation and appropriate management.
The recalled product
- Product
- IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
- Manufacturer
- Ideal Implant Incorporated
- Category
- Medical Device — Breast Implant
- Affected units
- 1,704
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers between 0100292 and 0102777.
Distribution
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