NOTICE – April 1, 2019
The IDEAL IMPLANT Quality Assurance team recently identified a small group of implants that deflated shortly after implantation due to a minute piece of silicone that dislodged from the valve channel during insertion of the fill tube. Investigations identified a minor manufacturing improvement that easily rectifies the chance of this issue occurring in the future. This will require us to pause implant production and sales until about June 3rd for implementation and verifications by the Quality Assurance team.
While not all companies would pause production for a minor issue such as this, we simply hold our product to a very high standard and wish to maintain the superior performance and patient satisfaction rates we have established.
Please note the following:
- Out of an abundance of caution, Ideal Implant instituted a voluntary recall of implants from this group that were not yet implanted.
- Out of 1704 implants in this group, about 3.3% deflated shortly after implantation.
- These implants met all specifications and inspections, so they are safe—there were no design or manufacturing defects.
- If an implant from the affected group is already in place, nothing needs to be done unless the implant deflates, in which case the warranty provides a replacement implant and financial assistance. If you feel you have a deflation, you should consult with your surgeon.
- A manufacturing quality process improvement is being made—the IDEAL IMPLANT design and specifications remain unchanged and proven (see 8-year performance data for capsule contracture and deflation compared to silicone gel in FDA trials).
While the patients we serve always come first, we certainly regret any inconvenience to our patients and surgeons who may have to briefly delay cases in the face of quickly growing patient demand for the IDEAL IMPLANT. We strive to be a different kind of implant company that proactively puts our patients’ best interests first. While this pause is certainly inconvenient, we have chosen to do it out of an abundance of caution to ensure that women can confidently choose “Beauty without Compromise” with the IDEAL IMPLANT for decades to come.
We sincerely appreciate your understanding as we act on behalf of the women we serve.