August 6, 2007 The number of breast enlargement operations performed in the US, for both augmentation and reconstruction purposes, has radically increased in the last decade. At the same time the number of operations to remove implants has also risen and given the potential surgical complications and health consequences of such surgery, many doctors find this trend troubling. Cytori Therapeutics, a Californian biotech company, has used stem cell technology to develop a more natural breast growth procedure and although it is still too early to determine their long term effectiveness, it’s possible that by avoiding the problems associated with current implants, the new approach could be a safer, healthier alternative.
In 2006, over 300,000 breast augmentations and reconstructions were performed in the United States, making them the most common type of cosmetic surgery and almost tripling the number of operations in 1997. According to statistics released by the American Society of Plastic Surgeons 56,176 were breast reconstructions with a high proportion (14,266) being operations to remove breast reconstruction. Although many patients who have undergone reconstruction or augmentation cite “aesthetic” reasons for reversal, there are several unavoidable medical factors present in the implant method. Breast pain is experienced by 6% of silicone implant patients and 16% of saline implant patients. A further 21% of women will experience a leakage of silicone from the implant which, aside from complicating the removal, can cause health problems and infections. 1-2% of implants are also prone to tissue necrosis which, even in the best case scenario, results in heavy scarring from surgery.
In order to address the high number of patients who desire the surgery, while avoiding the pitfalls, research has shifted to using the patient’s own organic materials in lieu of the unnatural saline or silicone. While fat carries less risk, it also brings with it unique problems – due to lack of blood supply withering is experienced over time. Cytori’s “Celution” uses a combination of fat and stem cells to incorporate the implant into the patient’s body, ensuring it has a constant supply of blood while avoiding issues associated with gel implants.
The process involves fat being taken using a minor liposuction procedure under local anesthetic from a patient’s buttocks or belly. The useful stem cells are separated out and an hour later, a dose of stem and regenerative cells is packaged into a cartridge ready for re-injection, without any culture or manipulation. The breasts then enlarge over about six months.
Using the method, breasts can increase in size by about two cup sizes. This range is less than that of current implant methods, but according to Cytori “looks more natural.” It is also equivalently priced, and involves about the same amount of time on the operating table, (though it takes six months for the breasts to reach their maximum size). Cytori Therapeutics’ initial focus will be on reconstructive surgery in breast cancer patients. Clinical trials involving breast cancer patients are underway.
The process was approved recently in Germany, which means that it is legal across the EU. But clinicians will have to wait until clinical trials end in early 2008 before they can recommend the procedure to their patients.