BioE Students Granted Provisional Patent for a Breast Implant Design that Mimics Natural Bodies

Breast implants in the 21st century provoke images of popular culture beauty icons, but their importance surpasses societal status throughout the world of biomedical engineering and plastic surgery. Last Spring, a Northeastern bioengineering student group realized a gap in the market of breast implants. They worked together to create a novel implant design that recently received a provisional patent.

One of the group members Christina Wheeler, MS’23, bioengineering, recognized the need for a safe and natural-looking breast implant following a discussion with a family friend. Wheeler’s friend suffered from breast cancer when she was in her 40s, receiving a single mastectomy. Following recovery, she chose to undergo breast implants. However, an issue arose: capsular contracture, or the hardening of tissue surrounding the implant leading to distortion. She chose to remove the implants due to this complication.

This discussion inspired Wheeler to approach her group in BIOE 5850 Design of Implants, with the idea to create a natural-looking breast implant. BIOE 5850 (taught by Professor Barenburg) requires students to design an implant that will meet an unmet need in healthcare. “We sort of identified … the niche of women who are post-menopausal … and those women who get mastectomies and want their breasts back,” Wheeler explains. The group consisted of Wheeler as well as bioengineering MS student Pooja Dandge and bioengineering BS students Maeve Hiehle, Caroline Orzech, Ellie Ruland.

Despite the demand for natural-looking implants, especially for breast cancer survivors, there are few options for those that would prefer to get implants similar to their natural bodies. If provided the option, Wheeler’s friend would have chosen to get an implant that looked like her natural breasts over the perky implants that are most advertised.

Figure 17 from Wheeler’s group’s final paper for BIOE 5850. Captioned “Relative comparison of hydrostatic pressure from side view, primary material (pink with blue arrows) and secondary material (purple with red arrows)” (p. 12)

With Wheeler’s friend in mind, the group considered multiple factors in creating the implant. This included the feel and movement of natural breasts, especially in relation to gravity. The design, named “Simplanta,” consists of an outer silicon shell filled with two immiscible materials. In order to maintain the movement of a natural breast, the design incorporates a dual-density filling (pictured). “The base idea is that it’s … a dual-density implant, two materials that are immiscible,” says Wheeler. “So that when you’re lying down it sort of spreads out like a natural breast would.” Additionally, Simplanta includes an Integra Dermal Regenerative Template (Integra DRT) coating, added in the hopes of preventing capsular contracture.

While there are other “natural” implants that are on the market or being developed, namely “Gummy bear” implants and Defy Gravity, obtaining FDA approval is a costly venture. “Breast implants are Class 3,” Wheeler states. “It means that they take the most regulation, the most time and consequently, the most money.” Luckily, Wheeler and her teammates are currently in the process of obtaining permanent patent rights over their design.

The group teamed up with the Northeastern Center for Research Innovation to obtain a provisional patent for their design. The provisional patent provides them legal protections over the design for one year. The group is expected to continue with the process toward an official patent over the next year.

However, given some gaps in the design and their statuses as students, Wheeler explained that the group has no near plans to pursue manufacturing the implant. “It’s out there … patents are open sourced and easily findable on the internet and if this convinces a company to make breast implants for post-menopausal women or helps someone get an idea for something else, well then that’s great.”

Ultimately, Simplanta and other designs like it provide much-needed options for people who receive mastectomies or others who are simply seeking natural-looking implants. According to the American Cancer Society, there are over 3.8 million breast cancer survivors in the United States, illustrating the potential demand for products such as Simplanta.

Students in the Bioengineering department such as Wheeler and her groupmates are continuing to perform necessary preliminary work encouraging future advances in the field of biomedical devices, healthcare and bioengineering alike.

Related Departments:Bioengineering