In the world of reconstructive surgery and oncoplasty there is still little talk about it, but in the future, breast implants may no longer be made of silicone. On the contrary: they may just not be there anymore. For some years, in fact, several companies, also in Italy, have been working on the idea of replacing silicone with fully biodegradable implants, which can restore a breast as natural as possible to patients: solutions that are definitive and, hopefully, without side effects. . The first clinical trials on small groups of women have already started.
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Breast cancer
Breast cancer is the most common cancer in the female population: one in three malignant cancer diagnoses in women is in the breast. Thanks to timely screening and increasingly effective therapies, however, survival today is around 88%. The therapeutic path foresees in almost all cases the partial (lumpectomy or quadrantectomy) or total (mastectomy) removal of the mammary gland, which is often followed by reconstruction, which is today considered an integral part of cancer treatment and, as such, is paid by the national health service.
The most common silicone implants
Silicone implants are used in most surgeries, which undoubtedly have many advantages, but which carry with them the disadvantage of having to be replaced (usually every 10-15 years), can give rise to discomfort and have been related to a form of lymphoma which – in very rare cases, it must be said – can develop in the breast.
“All over the world they are trying to find solutions other than silicone for breast implants: many are working to find materials that are less reactive and a little more natural for the body,” he says. Breast Health Mario RietjensDirector of the Complex Structure of Plastic and Reconstructive Surgery at the European Institute of Oncology and professor at the University of Milan.
Biodegradable materials
In general, the idea behind these prostheses, built with biodegradable materials thanks to 3D printing, is to provide a predefined structure (scaffold) that acts as a ‘scaffold’ or ‘fertile ground’ for tissue to grow in its place. of the patient herself, and which is reabsorbed without leaving any foreign body in the breast.
The first experimentation in France
One of these companies is French, Lattice Medical, and in recent weeks it performed the first implant of its fully biodegradable prosthesis in a patient operated on for breast cancer.
“We performed the first breast reconstruction surgery after a total mastectomy. It went very well and the patient is fine. We are the first in the world to implant a fully biodegradable breast implant after mastectomy, capable of regenerating autologous adipose tissue – he says. Julien Payen, CEO of the company -. For now we cannot say much more, we have to wait until September for further communications on the outcomes and on the state of health “.
Their prosthesis is a 3D printed cage, made of a degradable biopolymer, in which a small flap of tissue from under the breast area is enclosed. This flap grows to fill the cage with fatty tissue, while the cage itself is absorbed by the body in about 18 months. If the outcome is the one hoped for, a clinical trial will be launched which will last three years and will involve 50 patients in France, Spain and Georgia.
“We want to expand the use of our product, primarily in all breast reconstruction or cosmetic interventions, to remove the silicone implant,” says Payen. “But we also look further, such as the possibility of using these. technologies to regenerate the skin after severe burns or trauma “.
3D printers
To get to the same result you can follow different paths. According to reports from the Guardian, another French company, Healshape, hopes to begin its trial in the next two years. In this case, a hydrogel is used to 3D print a soft implant. Together with the insertion of the prosthesis, the patient’s fat cells are injected, which colonized the scaffold, while this disappears within six to nine months. The Israeli company CollPlant is developing something similar using a special bio-ink based on collagen extracted from tobacco leaves.
The resorbable prosthesis made in Italy
In Italy too, work is underway on the development of an innovative and bioabsorbable breast prosthesis for natural breast reconstruction and a second trial is about to start. “For several years I have been collaborating with an Italian company, Tensive, and a multicentre study that will involve three hospitals, including the IEO, is planned for this year”, confirms Rietjens.
Thanks to the support of funding from private, institutional and European Union investors, Tensive has already successfully completed preclinical tests and, from 2019 to 2021, conducted the first clinical trial on 15 patients who had undergone a lumpectomy for the removal of a non-malignant tumor at the Pisan University Hospital.
Evaluate security
Each patient was followed up for a period from 12 months to 28 months. The aim was to evaluate safety, compatibility with diagnostic techniques (such as classic mammography, for example), the impact on patients’ quality of life, their satisfaction and the possible onset of pain or adverse effects related to surgery. “The first experimentation ended in 2021 and went very well – continues Rietjens – It started with small prostheses, to then extend the experimentation to larger implants in the future, and maybe even replace silicone in breast augmentation. If the results will be positive, the material can be used in Europe in the near future “.
Thanks to the results of the preclinical phase, in fact, the company has already obtained the ISO 13485 certification for the design, development and production of the medical device. “Our company – comments to Salute Seno Alberto Cantaluppi, MD, president of Tensive – develops new solutions for reconstructive surgery. Among the different solutions there is this innovative breast prosthesis, REGENERA, designed to degrade over time and to be slowly replaced by the patient’s soft tissue, restoring the natural breast. Our goal – he concludes – is to revolutionize the multi-billion dollar market for breast implants, offering a safe and natural alternative to traditional silicone implants and fat transplants “.