This startup uses 3D printing to make breast implants and silicone-based prostheses for mastectomy survivors

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Breast cancer is a growing concern for women around the world. According to the WHO The data, 2.3 million women were diagnosed with breast cancer worldwide in 2020, and 685,000 women have lost the battle with the disease.

Sometimes, in order to treat or prevent breast cancer in people at higher risk, women have a mastectomy, which is a complete or partial removal of the breasts. Several doctors Resources confirmed that the prevalence of depression is common among breast cancer survivors. Mental stress and anxiety related to battling cancer takes a new hit after mastectomy, as women may face mental issues related to self-image and self-confidence.

Image Credit: Prayasta 3D Inventions

Based in Bangalore Prayasta 3D Inventions, founded by Shilpi Sen and Vikas Garg in 2017, seeks to help mastectomy survivors by developing new 3D printing technology to manufacture personalized breast implants and prostheses.

The startup aims to develop custom soft tissue implants and prostheses and began its journey by focusing on breast implants. This eventually focus on other tissue implants including the chin, nasal, lip, pectoral, malar and buttocks, among others.

Shilpi began researching the problem after losing her maternal aunt to breast cancer. While working in the communications segment at Nuffic’s Netherlands Education Support Office (NESO) in India, she met Vikas, who comes from the healthcare community with 3D printing skills and developing new 3D printing technologies for handling biocompatible materials.

Talk to Your story, the co-founders explain that there was a need to personalized breast implant of prostheses instead of all sizes to help women feel more comfortable. In order to achieve customization, the team built the entire printer from medical grade silicone in-house.

“The technology was developed in-house and the Silimac P250 printer was made from scratch to make our final product, ”explains Shilpi.

Silimac P250 [Image Credit: Prayasta]

Solve the problem of personalization

Fighting cancer and losing an organ in the process can lead to unimaginable mental stress. At such times, the last thing you need are sympathetic comments from others constantly reminding them of their implant or prosthesis.

Prayasta seeks to ensure individual customization according to the structure, size and shape of the female body, and ensures that the implant is closest to the natural organ.

Image Credit: Prayasta 3D Inventions

Vikas explains that the requirement for personalization is not only related to the look and feel of the organ, but also has health implications. Breast implants are usually filled with silicone gel, which has its own weight. If the weight of the implant does not match the user’s body weight requirements, it can eventually lead to back pain and posture problems, among others.

“We use the same silicone material that is used to manufacture current implants. What is different is the manufacturing process. Conventional implants are made using an immersion casting method using a mandrel made of metal or other material. Mandrel is practically a model of shape and size. We take this mandrel and dip it in silicone and put it inside to solidify the silicone. After repeating this process about eight to ten times, we finally get the silicone case, which then needs to be filled with silicone gel. The opening is then closed with another patch of silicone coating. This is how conventional breast implants are made, ”he adds.

Now the problem with this method is that the mandrels are prefabricated based on a generalized idea of ​​shape and size, and end users buy the model that suits them best. In the case of one-to-one personalization according to the conventional method, it will be necessary to have the whole of the mandrel produced, which is extremely expensive.

3D printing eliminates the need for a mandrel as virtualization becomes very easy. One can design the shape, size and shape in a computer and the printer can directly take input from that computer. Apart from that, it also eliminates the need to fill with silicone gel or saline solution inside.

The co-founders explain that in case of implants filled with saline solution or gel, if the user has an accident that ruptures the outer shell, the implant will need to be changed immediately as silica gel can be fatal. For this reason, traditional breast implants are not suitable for sutures.

In case of 3D printing, the the finished products are waterproof, suturable and balanced according to body weight, and also ensure body symmetry.

“It is also very important that the feel and feel of the implant once implanted is as close to the natural organ as possible, but the natural tissue differs from person to person. Thus, personalization makes it possible to meet this challenge, ”he adds.

Shilpa informs that the 3D printing technology developed by Prayasta has been granted a patent in India, and the startup has also filed for patents in the United States and Europe.

Illustration: YS Design

Plan ahead

Shilpi reveals that implants and invasive medical devices require regulatory testing and approvals, which can take up to five to six years before being launched commercially.

However, Prayasta seeks to commercially launch its prostheses on the market in the next six months. The prototype is ready at the moment and wants to be tested.

“We are now looking to establish partnerships with NGOs, hospitals, health facilities, etc., which will help raise awareness, educate women, educate doctors and other health professionals on the reasons why the personalization is needed, ”she adds.

According to a report By Fortune Business Insights, the global breast implants market size was valued at $ 2.76 billion in 2019 and is expected to reach $ 3.05 billion by 2027, growing at a CAGR of 7.2%.

Although the technology is relatively new, another player in this space is Lattice Medical, based in France, which is developing a 3D printed bioabsorbable and tissue implant for breast reconstruction surgeries.

Vikas, however, highlights a problem in the Indian market. He explains that in most Western countries surgery is covered by health insurance. However, this is not the case in India as breast implant surgery is widely considered to be cosmetic surgery. He explains that there is a need for awareness about this in the market to understand that breast implants can be important for cancer survivors.

Prayasta started his journey with a grant from DST under Nidhi Prayas. It has also won numerous competitions and is supported by grants from the MSME Center of Excellence, the Indian Institute of Science under Design Clinic, the DERBI Foundation, the Biotech Ignition grant from BIRAC and the Startup Karnataka grant under ElevateCall2 .

“We are now open to fundraise to continue our journey. We are also looking to create a clinical advisory board where we can seek help and advice from medical specialists in these areas, ”adds Vikas.


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