Patients pleased with cohesive silicone gel breast implants
Jun 1, 2004 – Nancy Groves, Cosmetic Surgery Times
Vancouver, British Columbia – Cohesive silicone gel implants provide a natural, proportionate look for women undergoing breast augmentation or reconstructive surgery and offer them a variety of options for obtaining the best fit, according to Mitchell H. Brown, M.D., FRCSC, a plastic and cosmetic surgeon in Toronto. Results of a study he conducted in his practice also show that women who have received these implants are extremely satisfied with the outcome.
“I think that the key aspect of the gel implants is that they provide a very natural and proportionate looking breast augmentation,” Dr. Brown said. “For women who are looking for a large, full, round, nonproportionate augmentation, this would not be the implant of choice.”
The cohesive gel implants also feel more natural than saline implants, Dr. Brown said. “That’s because the cohesive gel implants have enhanced memory, retain their shape, and are textured on their surface, so they integrate like Velcro underneath the breast; the breast and the implant move together, as opposed to a saline implant that tends to move as a free-floating object.”
53 year old woman following two stage breast reconstruction using an MF525 cohesive gel implant under the muscle. The patient has also had a balancing mastopexy on the right.
In addition to earning high marks from patients, the implants have a complication rate similar to or less than those seen with saline or regular gel implants, Dr. Brown said. He uses a style 410 cohesive gel implant manufactured by Inamed.
Dr. Brown presented a paper on his experiences with cohesive silicone gel breast implants at The Aesthetic Meeting 2004, sponsored by the American Society for Aesthetic Plastic Surgery.
The paper described his initial 150 consecutive patients undergoing cohesive silicone gel breast implantation between October 2001 and June 2003. Within that group, 118 had breast augmentation and 32 had breast reconstructive surgery. Since preparing that paper, Dr. Brown has used the cohesive gel implants on additional patients for a total of about 260, and has observed that outcomes have changed little from the initial results.
Need the nod from FDA
Dr. Brown began using the cohesive gel implants about a year after they became available in Canada under a process that requires special approval by Health Canada for each case. The implants have been used in Europe since 1993 but have not received FDA approval in the United States.
Among the 118 study patients in Dr. Brown’s practice who received implants for breast augmentation, the most common reason was breast hypoplasia, often following pregnancy; a number of women had abnormal breast development, such as a tuberous breast deformity.
A total of 235 implants were used in the 118 patients. “Patient outcomes in general were excellent with a very high degree of patient satisfaction,” Dr. Brown said.
Minor complications occurred in four of 118 patients (3.4 percent). They included one case of hematoma, two cases of minor tightening of scar tissue around the implant, and one instance of asymmetry of the inframammary fold under the breast. The asymmetry occurred in a transgender patient and was corrected in a second procedure. There were no cases of rotation, infection, or loss of implant integrity.
Results were similarly good in the breast reconstruction population, most of whom underwent reconstruction following a mastectomy. Complications occurred in six of 32 patients (18.8 percent), but five of the sixcomplications were minor and did not require any further therapy.
According to Dr. Brown, cohesive gel implants are less liquid than earlier gel implants, having a consistency similar to Gummi bear candies. With earlier varieties of liquid gel implant, the gel could potentially leak into surrounding breast tissue in the event of breakage and could cause problems such as lumps or difficulty in removing the entire implant.
However, the cohesive implants are more stable. “If one of these implants were to break, then the gel would stay within the shell; it would be easier to remove it in its entirety and replace it with a new implant,” Dr. Brown explained.
Another benefit of the cohesive gel implant is that it comes in a great variety of shapes and sizes, he added. It is available in round and teardrop-shaped forms, with a matrix of three variable heights and four projections that give women a choice of 12 styles. In addition, each style is available in 10 or 11 sizes.
“There are well over 150 options of cohesive gel implant, which makes it ideal for matching the exact dimensions a patient may be looking for in terms of either breast augmentation, breast asymmetry, or reconstructive breast surgery after a woman has had a mastectomy to try to match the shape and size of the opposite breast,” Dr. Brown said.
Dr. Brown is currently a medical consultant to Inamed Aesthetics Canada, although he did not have a relationship with the company during the reporting period described in his study.