Inert insert

Key Points

Brisbane, Australia — Capsular contracture following breast implant surgery is, unfortunately, a well-known complication occurring in five to eight percent of breast implant patients whether receiving saline or silicone gel implants. However, a new implant featuring a titanium-coated silicone elastomer shell has been identified as a possibility for preventing this complication. The novel technology is the brainchild of a French company, Poly Implants Prostheses (PIP). "The implant shell is created normally, but, before it is filled, it undergoes a process whereby titanium molecules are covalently bonded to the silicone molecules on both sides of the shell. It effectively creates a layer that is 30 nm thick — about 3,000 times thinner than one human hair," explains Daniel Fleming, M.D., F.A.C.C.S., founder of the Cosmetic Surgery Institute of Australia, Brisbane. "You cannot see or feel the difference between a titanium implant and a regular implant. [It] has the same properties...in terms of its tensile strength and pliability, [nor does] it affect mammograms, x-rays, airport scanners or MRIs."

When the implant is placed, the patient's tissues are in contact with the implant's titanium surface as opposed to silicone molecules. According to Dr. Fleming, titanium is the most inert foreign substance that can be placed in the body, accounting for its wide application in medical devices from heart valves to dental implants.

COMMON DENOMINATOR "We do not know the etiology of capsular contracture, but the causes are certainly multifactorial," says dr. Fleming. Though possible causes are varied — infection, radiotherapy, hematomas and idiopathic causes — a common denominator exists: chronic inflammatory response. as such, it makes sense to use an implant that has less possibility of inciting such a response. "titanium is not only bacteriostatic, but also has anti-inflammatory properties. in theory, by reducing the inflammatory response, we can reduce the rate of capsular contracture," he tells Cosmetic surgery times.

"The titanium coating has been proven in vitro to reduce gel bleed [microdiffusion of silicone molecules] by 25 percent compared with standard implants. An inflammatory reaction to gel bleed has also been implicated in capsular contracture," he notes.

In Australia, Dr. Fleming is currently heading the world's first two-year, 1,500 patient trial using these titanium breast implants with the objective of significantly reducing capsular contracture. Statistically, approximately 90 percent of the capsular contractures arise within the first 12 months following the procedure. Of the remaining 10 percent, the majority occur within the next 12 months. Though early, (the study began in November 2006) results thus far look good. "We have not found any disadvantages with the titanium implants to date and [they] have been problem-free. They behave exactly the same as ordinary implants," he says.