The Recall Desk
SevereFDA (Devices)·Z-2219-2019·Announced 2019-08-14

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Related recalls

Same hazard · deflation

See all →