A German company called BellaSeno focuses on making 3D-printed resorbable breast implants. These implants can be used for breast augmentation (making the breasts larger) and for a procedure called lumpectomy (removing a part of the breast). The company has finished two clinical trials for these resorbable breast implants. These trials are the first time that polycaprolactone (PCL) scaffolds have been used in implants that are meant to be completely absorbed by the body and then replaced with natural tissue.
The trials were studies that were sponsored. They were single-arm (only one group of patients), open (not a blind study), mono-centric (at one location), interventional (involved an intervention), and prospective (looked forward in time). The main goals of the trials were things like the safety of the device after surgery. The secondary goals included the safety of the patients after surgery and how well the device worked, such as improving the quality of life and replacing the right volume of tissue.
In 2022, there was a breast augmentation trial with 19 Australian patients. These patients recently took part in a follow-up study. Importantly, none of them needed to have the scaffold removed or have a revision surgery. The company said, “The assessment after one year shows that BellaSeno’s resorbable soft tissue implants have a very good safety record. There were no major problems like capsular contracture (when the tissue around the implant tightens), calcifications (hard deposits), oil cysts, infections, tissue death, or issues with wound healing. No scaffolds had to be removed or replaced, and there were no scaffold-related problems in any patient six months after the surgery.”
Another trial involved 7 patients with pectus excavatum. This is a condition where the breastbone is sunken. This trial also reached the one-year follow-up mark successfully.
BellaSeno uses polycaprolactone (PCL) scaffolds. PCL is a very safe and well-known material. It has great properties. For example, it has a high tensile strength (it can handle a lot of pulling force) and its elongation is more than 1000%. It can also be resorbed by the body. The time it takes for PCL to be absorbed can be partly controlled. With 3D printing, it’s possible to make custom scaffolds that can make a patient’s body more symmetrical or create a specific shape.
An Independent Data Safety Monitoring Committee looked at the one-year follow-up data. They decided that all the bad events that happened were within the normal range for removal and replacement surgeries. The same results were seen in the one-year follow-ups for both the breast augmentation and pectus excavatum trials.
In the field of additive manufacturing (3D printing), BellaSeno’s progress and the work on 3D-printed PCL implants by other companies are areas that are closely watched. If the effectiveness and safety of PCL implants can be clearly shown, there’s a lot of potential for growth. 3D printing can be used for things like treating trauma in oncology (cancer treatment), general trauma, fixing the nose, and different facial procedures. Any time the body needs structural augmentation or preservation, it could benefit from using these scaffold-based methods, like what BellaSeno, Lattice Medical, and 4D Biomaterials are doing.
I think that the next big success in this area is going to come from a company like BellaSeno. If someone asks me which company will be the leader in additive manufacturing in the next ten years, I’m not sure. But I would bet on BellaSeno instead of an original equipment manufacturer (OEM).
BellaSeno is also solving a real problem. Breast augmentation is a popular thing in culture and is a common procedure that many people ask for. But there are problems with the traditional ways of doing it. For example, silicone breast implants have been linked to some cancers, and there are many other complications too. In the United States, there are more than 300,000 breast augmentation surgeries every year. So the risks and the potential market for a safer solution are huge.
BellaSeno is dealing with an important and urgent need. Breast augmentation is still a common practice, but the problems with traditional methods are serious. Silicone implants, for instance, have cancer risks and other common issues. With over 300,000 breast augmentations in the U.S. each year, the risks show how big the problem is, and also how big the market is for safer options. This is good news for BellaSeno and the whole 3D printing industry.
Since 2015, BellaSeno has been making steady progress in developing 3D-printed PCL implants. Innovations like this take a lot of time, patience, people to participate, and a lot of money. Success isn’t guaranteed because clinical trials are strict and expensive. They are designed to find any potential problems and risks. But BellaSeno is slowly becoming one of the most successful companies in additive manufacturing. In fact, the company plans to start a study of its resorbable breast scaffolds in the U.S. and Europe. It also wants to use its scaffolds more for primary breast augmentation and lumpectomy. And it will finish a two-year follow-up study next year.
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