Ideal Implant Incorporated, a company that created, manufactured, and marketed a once novel breast implant said Wednesday, May 31st, that it has ceased all of its operations and is in the process of liquidating its assets.
The company was founded in January 2006, received FDA premarket approval on its implants in November 2014, and ceased all operations on May 30, 2023.
In an email to providers, the company cited its inability to generate sufficient income and investments to ensure the financial viability of the company, giving them no other alternative but to liquidate.
“We have been unable to generate sufficient income from sales or to secure the capital investment necessary to maintain financial viability of the company.”
Statement by Ideal Implant, Inc., June 1, 2023.
The company’s website and social media accounts are no longer live.
Ideal Implant, Inc., was the subject of a May 2022 lawsuit by a patient whose implant reportedly deflated and, like all current U.S. breast implant manufacturers, had received an FDA warning letter for failure to comply with its post-approval study requirements, but had an otherwise positive 17 years of operation.
In January 2022, a study, financed by Ideal Implant, Inc., and conducted by Dr. Marc J. Salzman, found that just over 10½ percent of women with silicone gel breast implants had a silent rupture of which they were unaware, amounting to an estimated 300,000 U.S. women being potentially affected.
The Ideal Implant came with a protection plan that provided free lifetime replacements for deflation, and 10 years of coverage for capsular contracture.
The company is reportedly unable to honor these warranty claims any longer.
“Existing and future warranty claims cannot be processed and we have no funds available to pay any warranty claims. If you have questions about the liquidation process, please contact our attorney…”
Statement by Ideal Implant, Inc., June 1, 2023.
The company, founded by world-renowned plastic surgeon Robert S Hamas, M.D., received FDA approval to market its implants in September 2015.
Its implants were believed by many to be a combination of the best parts of both saline and silicone breast implants.
An internal baffle system prevented a saline solution from sloshing around, and helped the implant maintain its shape, while its saline fill allowed for external observation of rupture or leakage.
Surgeons who used the implant called it a “game-changer for breast augmentation,” and it was only available to surgeons who were board-certified by the American Board of Plastic Surgery.
Studies suggested the Ideal Implant had a lower rate of both deflation and rupture, and of capsular contracture, some two times lower than other breast implant brands.
Upon Ideal Implant’s FDA approval in late 2015, Hamas summarized his purpose in creating the novel implant:
“After years of dealing with ruptured silicone gel implants and listening to patient complaints about the unnatural feel of original saline implants, I realized that women were looking for a new type of breast implant. This led me to develop the IDEAL IMPLANT,” said Dr. Robert S Hamas, MD.
“Now, for the first time, women can have a breast implant that offers them a natural feel without silicone gel. It has only saline inside for their safety and peace of mind. Unlike silicone gel implants that have a high incidence of silent rupture that requires an MRI scan for detection, with the IDEAL IMPLANT, a woman can look in the mirror each day and have the confidence of knowing her implants are intact.”
Ideal Implant Not Recalled, Prophylactic Removal Not Newly Recommended
The Ideal Implant is no longer available to patients not because of an FDA recall or the discovery that something was wrong with the prosthetic, but because the company that invented and brought it to market failed due to lack of finances.
It couldn’t maintain profitability, nor find investors willing to keep it afloat, something it had been trying to do since at least October last year.
The breast implant manufacturer’s permanent closure comes as U.S. plastic surgeons report losing an aggregate estimated half-billion dollars per year, due to a decline in the number of breast augmentation surgeries being performed.
Women with the Ideal Implant have not been advised to have them removed. Problems may arise, however, if the implant deflates or fails, as they are no longer covered by warranty.
June 1, 2023
Statement Issued by Ideal Implant, Inc.
via IdealImplant.com, Accessed June 2, 2023
Ideal Implant Incorporated has Ceased Operations and is Liquidating
With deep regret, we must inform you that Ideal Implant Incorporated ceased all operations at 5:00 pm CT Tuesday, May 30, 2023. We have been unable to generate sufficient income from sales or to secure the capital investment necessary to maintain financial viability of the company. Through a formal search process, our investment bankers were unsuccessful in finding an investor or acquiror that would keep Ideal Implant operating. We had been in extensive negotiations that would have provided for past and future warranty claims to be assumed by the acquiror in exchange for signicant [sic] financial concessions, but negotiations with the potential acquiror ended unexpectedly late Tuesday afternoon. We were left with no other alternative than to cease operations and liquidate.
Effective immediately, no implants will be shipped and no returns will be accepted for credit. We do not have sufficient assets to satisfy our secured creditor, therefore, there are no assets or funds available for any other creditors of the company. Existing and future warranty claims cannot be processed and we have no funds available to pay any warranty claims. If you have questions about the liquidation process, please contact our attorney:
[Please see editor’s note, below.]
Jerey M. Rosenthal
Mandelbaum Barrett PC
3 Becker Farm Road, Suite 105
Roseland, NJ 07068
JRosenthal@mblawrm.com
Ideal Implant was founded in January 2006. Since then, a dedicated team of engineers, consultants, administrators, advisors, sales representatives and investors has worked to develop and refine the Ideal Implant and make it available to women as an alternative to the original saline and silicone implants. We want to thank everyone for their professional and personal dedication to this goal over the last 17 years. Many surgeons and patients embraced this new technology implant and were happy with the clinical results. Unfortunately, the company does not have the financial resources to continue in business.
Editor’s Note: The Statement issued by Ideal Implant, Inc., contains significant typographical errors. The website URL provided, “mblawrm.com,” does not go anywhere, and an email sent to the address provided bounced back as undeliverable Friday afternoon.
- The Statement should point visitors to this website address: https://www.mblawfirm.com.
- The correct email address for questions about the liquidation process appears to be jrosenthal@mblawfirm.com.
Updated June 2nd to add the company’s statement at close, an editor’s note, and two excerpts.