At an FDA panel this week, breast implant illness survivor Jamee Cook posed an important question to the experts seated before her.
“[Women with breast implant illness] are ignored and laughed at. Some are having financial stress. Some are struggling to care for their children. This isn’t the life I pictured for myself. Doesn’t the upcoming generation of women deserve better?”
A new generation of breast implants aim to provide just that: an alternative to the current models, which are under scrutiny for links to illness—one focus of the two-day public hearing hosted by the Food and Drug Administration in Silver Spring, Maryland.
Whether constructed with nesting shells or made with 3-D printers and a patient’s excess fat, the newer implants aim to reduce the risk of rupture and avoid materials and designs that some blame for making women sick.
Breast implant illness varies from person to person, but the top five most reported symptoms are memory loss, brain fog, fatigue, joint pain and rash. These symptoms or others begin after breast implant surgery and usually subside after explant. Breast implant-associated anaplastic large cell lymphoma is an emerging type of non-Hodgkin’s lymphoma affecting women with implants, specifically textured ones, usually eight to 10 years after surgery.
Current implants come in different shapes and roundnesses, but are generally made of a silicone shell filled with saline or silicone gel. Their shells can be smooth or textured, which is intended to keep them from rotating or migrating once implanted. Research on post-implant lymphoma is limited and breast implant illness isn’t even a recognized clinical diagnosis, but researchers are moving forward with new implants in hopes of eradicating the complaints.
Today, approximately 100 surgeons in the U.S. are using IDEAL implants. The company refers to them as structured implants, a new type of implant altogether.
The IDEAL Implant is constructed of multiple shells nested within each other to control the movement of the saline inside. In case of a rupture, that saline can be absorbed safely by the body. The silicone shells provide a natural feel without the risk of silent rupture associated with silicone gel-filled implants, which can burst open without the patient knowing unless they have an MRI.
So far, there have been no reports of illness in patients with this style of implant, but research must continue before it becomes widely available.
The FDA and Health Canada granted approval to use the implant in November 2014. Forty-five American Board of Plastic Surgery–certified plastic surgeons enrolled 502 women into a study and completed a six-year follow-up of 438 of those participants. The study found approximately 90 percent of patients were satisfied with their results and the rates of rupture and capsular contracture — when the naturally occurring scar tissue around an implant contracts and hardens — were relatively low.
“It’s called a structured implant,” said Dr. Ankit Desai, a plastic and reconstructive surgeon at Baptist MD Anderson Cancer Center in Jacksonville, Florida, who focuses on reconstructive surgery for breast cancer patients. “It has chambers, and the marketing says they have a more natural feel that gets closer to silicone gel’s feel but doesn’t have actual silicone inside of it. So, if you do have a rupture, you’ll know because your implant will deflate. There are no silent ruptures with saline implants.”
Another company, Lattice Medical, has created the Mat(t)isse 3D-printed breast implant, which is not yet approved for human trials. When using Mat(t)isse implants, doctors would take measurements of the patient’s breasts with an MRI so a 3D printer could create a custom implant with a lattice-like shell specific to that patient’s body. The shell would be filled with the patient’s own fat cells and surgically implanted. In theory, the shell supports the breast’s shape while allowing the fat cells to thrive in their new location and grow in the correct shape. Over the course of six months, the shell would be absorbed by the body, leaving a shapelier result than traditional fat transfer.
These implants exclude both saline and silicone to avoid related risks like rupture, contracture and leaking. Dr. Julien Payen, founder of Lattice Medical, and Dr. Pierre-Marie Danze, researcher at the Centre Hospitalier Regional, Lille University in France, received the Théophile Legrand Textile Innovation award in 2017 for their creation. But Desai says it could be years before a 3D-printed device is approved for use in real patients.
“There is no 3D-printed implant close phase II trials,” said Desai. “There’s a lot of data to gather before you can get FDA approval. It’s a huge burden of data to collect, hence there’s a high cost to getting these trials through the FDA. There probably won’t be a 3D implant ready for that for five to 10 years.”
Implant-related lymphoma is associated more often with textured implants than smooth ones, and one implant manufacturer pointed out during Monday’s hearing that some textures may be safer than others.
Mentor, one of the two breast implant manufacturers who has yet to produce long-term study findings on their implants for the FDA, spoke about breast implant safety at Monday’s panel gathering. Their representative said that while the origin of anaplastic large cell lymphoma is likely multifactorial, studies show it could be the result of biofilm (bacteria on the surface of the implant).
Because textured implants have more surface area than smooth ones, they could harbor more bacteria which may cause inflammation and trigger disease, according to this study sponsored by multiple implant manufacturers. Mentor noted that textured implants with holes or lattice-like patterns may host more bacteria than their own, the surface of which is made up of microscopic peaks and valleys.
“In the 660 reported cases of BIA-ALCL, if you looked at each specific case, the Mentor implants that have less aggressive texturing had a significantly lower number of those cases, like 50 or less. There probably is something to that — the greater surface area and roughness there is, there’s probably increased chances of creating that inflammation,” Desai said.
With the safety of implants in question, women who want augmentation but aren’t comfortable using any devices could opt for using their own fat.
“The most common non-implant augmentation is fat grafting,” said Desai. “The procedure involves liposuction to remove fat from one part of the body and inject it into the breast to add volume.”
The procedure is not used as often as implants because it can be harder to achieve the cup size a patient requests, particularly if they don’t have enough body fat.
“The fat, depending on how much you have elsewhere and how much space there is to inject, can make a half- to one-cup enhancement, much like what we’ve been doing for years with buttocks,” Desai said.
As the FDA continues looking into implant safety, the panel agreed patients should talk to their surgeons about all the risks and benefits associated with breast implants before consenting to augmentation. Desai said it’s crucial for surgeons to fully inform their patients of exactly what is known about implants so patients can make informed decisions.
“BIA-ALCL is a real disease that happens. It’s exceedingly rare, but we’re just starting to understand it,” he said. “I can’t imagine anyone putting in an implant without informed consent. I always disclose to patients there are risks and there are benefits. It has to be part of their decision.”