The Pocket Protector (Surgiform Technology) works well with either saline or silicone gel breast implants, says Mark Berman, M.D., F.A.C.S., clinical instructor of facial plastic surgery at the University of Southern California.
"It's basically an expanded polytetrafluoroethylene (e-PTFE) device built around a very simple concept. It contains a bladder that lines the inside of a breast pocket, and the breast simply grows into the bladder without forming a scar around it," he explains.This way, he says the Pocket Protector integrates with the surrounding tissue and prevents the body from closing down around itself.
"That keeps the space relatively open," Dr. Berman tells Cosmetic Surgery Times, "so one can just float the implant inside that space. Therefore, the breast remains soft and natural."
In the study pipeline
Dr. Berman says that by providing this function, the product is especially helpful for reconstructive breast surgery and revision breast augmentation in patients who have developed hard capsules around traditional breast implants.
At press time, Dr. Berman had submitted a Food and Drug Administration (FDA) investigational device exemption (IDE) application to study the device in these types of patients.
He adds, "Hopefully, we'll start studies soon on primary patients as well. That's going to really change the way we do breast surgery."
To date, Dr. Berman says that nationally, he and his colleagues have treated 157 cases with his innovation, though as of early January greater than 50 additional patients of Dr. Berman were awaiting approval of the IDE application.
As with any synthetic material, Dr. Berman says risks of his product include infection, as well as contamination (which could lead to seromas and non-incorporation into the tissue). "Four patients developed seromas," he says, all of whom had received implants during flu season.
Dr. Berman says one of these patients in fact later revealed that she had the flu one week before her procedure but told him it was a cold. "The surgery went really well," he says, but the next day the patient complained of body aches, fever and chills.
Soon, Dr. Berman says, the implants swelled. About 10 days after surgery, he removed the Pocket Protectors — which he says looked fine — and suctioned off the fluid that had built up around them. Six months later, he redid the implantation. "She is now two years post-op," he says, "with soft, natural breasts for the first time in her life."
Additionally, one patient upon whom Dr. Berman had performed a standard mastopexy, along with insertion of Pocket Protectors and implants, developed an infection. Dr. Berman says he removed her implants and successfully replaced them six months later.
"The problem with e-PTFE is that it's pretty delicate. Because it's microporous, if one gets any contamination in it, it will (compromise) the pores, and the body can't react to it naturally," he says.
Conversely, Dr. Berman says that if the patient heals normally, the body fully incorporates the implants within about three months, leaving no evidence of foreign body reaction or degradation of the material.
Because the e-PTFE used in the Pocket Protector measures 40 µm (millimicrons) in porosity, he explains, it elicits ingrowth of blood vessels and connective tissue into its interstices, rather than concentric scar tissue formation.
Likewise, he says because the Pocket Protector measures just .35 mm thick, the material provides adequate ingrowth and tensile strength while being thin enough to avoid palpability.