Ideal Implant
President and CEO of Ideal Implant, spent nearly his entire career in private practice as a plastic surgeon in Dallas, Texas, in the United States. Breast augmentations were a large part of his practice and these were a cause for patient concerns, due to problems common to existing silicone gel-filled or saline filled implant options.
Silicone gel implants offer a natural look and feel but risk rupture, leading to silicone leaking from the implant into surrounding tissues. Unfortunately, ruptures are “silent” and can only be detected by an MRI or ultrasound scan, which the US FDA recommends patients obtain every two to three years for life.
Saline-filled implants deliver peace of mind because saline is harmlessly absorbed by the body in case of rupture. However, the implants have no structure, resulting in uncontrolled movement of the saline, as it moves around and wrinkles, feeling unnatural.
Dissatisfied with the status quo, Dr. Hamas embarked on a mission to design a totally new type of breast implant. “After years of dealing with silently ruptured silicone gel implants and listening to patient concerns,” says Dr. Hamas, “I realized that women wanted a new type of breast implant – one that would combine the natural feel of a silicone gel implant, but with only saline inside for safety and peace of mind.”
Finding Inspiration
In 1992, Dr. Hamas and his wife were in flight when the plane encountered turbulence. It was nothing out of the ordinary. However, Robert noticed that his beverage, which contained ice, did not slosh around at all, while his wife’s, which did not contain ice, splashed out of the glass. Why did the ice control the movement of the liquid? Could that concept be applied to a saline-filled breast implant? Something about that observation clicked for Dr. Hamas, and his mind went to work.
Something about that observation clicked for Dr. Hamas, and he spent the next 14 years developing and testing prototypes that he passionately believed would change women’s lives and give them peace of mind by combining the natural look and feel of silicone gel implants with the safety of saline. He simply needed the right manufacturing partner to make his invention a reality. It was at that time, in 2006, that Dr. Hamas officially founded the company, Ideal Implant Incorporated.
Not long thereafter, Dr. Hamas began work with a small manufacturer to help produce this innovative implant. However, it quickly became evident that this firm did not have the
manufacturing sophistication and engineering expertise required to develop commercial-scale manufacturing of the product, ensure consistent high quality and ramp up production to meet future demand for large quantities. After a few years of struggling to make headway, Dr. Hamas partnered with Specialty Silicone Fabricators, which Trelleborg acquired in 2016.
A Great Partnership
Working together, Ideal Implant and Trelleborg developed a robust manufacturing process that delivered the superior quality that Dr. Hamas desired. This partnership and close collaboration ultimately brought about FDA approval of the first new type of breast implant in decades, which led to significant sales growth in the United States and Canada.
“Working with Trelleborg, I was impressed that the team consistently looked at the long-term success of our product. They were not focused solely on the bottom line,” says
Dr. Hamas. “I know that with Trelleborg as a partner, our business is in good hands.”
Complex Manufacturing
Ideal Implant’s breast implant comprises a series of internal baffle shells nested together and two separate chambers to hold the saline. The unique design controls movement of the saline and supports the shell to reduce collapsing and wrinkling, thought to be the main cause of ruptures. This internal structure is what gives the implant its natural look and feel, so silicone gel is not necessary and women no longer have to be concerned about “silent rupture” and the need for regular MRI scans to detect ruptures.
Manufacturing and assembly are challenges due to the complexity of the implant’s design and need for consistent quality. Initially, Trelleborg used Ideal Implant’s bespoke manufacturing equipment to produce the implants and then manually assembled the dip molded subassemblies - a process that requires a high level of expertise to ensure quality and consistency. While the Trelleborg Healthcare & Medical team had extensive experience in producing consistent, high-quality subassemblies, the production equipment was not able to meet the increasing demand from surgeons and patients who preferred Ideal Implants.
Preparing for Growth
To gear up for future growth, Trelleborg Healthcare & Medical invested in all new equipment, adding precise automation to ensure high-quality and increased efficiency in the dip-molding process, while ensuring that custom-design elements integral to the Ideal Implant manufacturing process were implemented in the new production system.
Installation and validation of the new equipment is a lengthy process, which could have delayed scale up, potentially for several months. To accelerate the timeline, Trelleborg’s
engineering team proposed a plan to assemble the implants in-house, using shells and components produced by the original equipment. Ideal Implant approved the proposal, and Trelleborg has assembled implants since the third quarter of 2020, while concurrently managing the new equipment validation process.
Once the validation is complete, the old equipment will be decommissioned and the entire production process conducted in-house at the Trelleborg Healthcare & Medical manufacturing facility in the United States. The new, enhanced manufacturing capabilities will help Ideal Implant meet growing demand in Canada and the United States, while also allowing expansion to other international markets.
Dr. Hamas retired from his medical practice in 2016 and now dedicates 100% of his time to managing the Ideal Implant business. His vision for this novel implant has been realized, and his sights are now set on expanding to Europe and beyond. Trelleborg’s global footprint will enable him to do that.