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ParfumGigi@aol.com

17 janvier, 2007 18:18

Silicone breast implants coming back after ban

Some consumers remain skeptical, think saline is still the safer option Fifteen years after they were banned from use, silicon breast implants are back, but manufacturers will have to overcome old concerns about safety to win back consumers' trust.

"I wouldn't get silicon," said Jennifer Saab, 19, of Clinton, who had saline breast implants inserted by Dr. Phillip K. Blevins as her graduation present when she was 18 years old. "If they have taken it off the market, why put it back on if it has hurt people before and it has been bad before? If saline is out there and it is better, why not use that?"

 

 

The Food and Drug Administration re-approved the use of silicon breast implants made by Allergan and Mentor in November 2006, 44 years after the first silicone implant surgery was done. Silicon breast implants were banned in 1992 except for women in clinical studies.

"When I came into practice, literally that month, Connie Chung went on the air, saying they were harmful," said Dr. Kenneth R. Barraza, a plastic surgeon with The Face and Body Center of Plastic & Hand Surgery Associates PLLC in Flowood, since 1991. "There was a multitude of litigation, but there was no real hard data that silicon gel was harmful."

Barraza took over a practice from a retiring physician who had been inserting silicon implants.

"I took them (silicon implants) out right and left because women were terrified," he said. "Occasionally, a patient was having a problem we needed to address." Barraza replaced the silicone implants with saline implants.

Barraza said the FDA and implant manufacturers have been working on large studies, to determine if silicon gel is linked to medical issues such as chronic fatigue syndrome and rheumatoid arthritis in women.

"They didn't see any difference in women with or without silicon gel implants," he said. "Most of the study results came in that they were safe."

Safety was a top concern for Saab.

"My grandmother, my mom and I discussed being safe," she said. "I had mine done behind the muscle. "

Saab said her doctor told her it was safer, makes it last longer and makes it look more natural.

Saab described her breasts before implants as "really small, an A (cup), not even an A (cup)." Now, she describes her breast as being a "good C (cup)."

"I was basically real flat and I worked out a lot, and I kicked my figure up and everything else looked good, so why not that?" she said. "Why not have everything?

In appearance, Barraza said he thinks the saline and silicon implants produce the same results in most patients. "Some people think there is less rippling with a gel implant," he said. "I don't necessarily think that. I think you get rippling with both."

Barraza described rippling as "the wavy pattern on your skin surface that you can see or feel."

Barraza said he prefers to use saline implants.

"In specific situations when it is beneficial to use gel implants, I will use them," he said. "We have 10 doctors who work in this facility, and I don't think anyone is using the silicon implants as their primary augmentation tool.

"In the early '90s, the problem with the old implants was that the shell would break," Barraza said.

He said the outer shell was a fairly thin, hard silicon polymer shell that surrounded a silicon gel that was more like a liquid. Today, the silicon has a thicker consistency.

"Today, if you cut the implant in half, it stays in place because it has a consistency similar to gummy bear candy, in the past, you cut it and the gel ran out like a liquid" he said.

The FDA only has approved unconditional use of silicone gel implants that have a cohesive-gel consistency similar to Jello-O, according to Dr. Shelby Brantley of Plastic and Hand Surgery Associates in Flowood. Brantley said women must meet certain criteria and be included in a clinical study to have implants with a gummy bear consistency. Silicone implants banned from use had the consistency of cold syrup, Brantley said.

"Today's shells are thicker and less likely to break down, it has more texture and body to it," Barraza said.

The saline implant also has a silicon polymer shell.

"It's like a bag filled with salt water," he said. If it breaks, the shell remains, but you lose the effect. There is no danger or consequence, it just has to be replaced and the volume restored."

Barraza said the saline solution is used because if it leaks from the implant, the body won't adversely react to it.

"Another difference is when I put a saline implant incision, I can make a really small incision," he said. "[With] Silicon gel implants, you have to make a longer incision."

Barraza described the saline procedure as a roll up procedure. He makes a small incision, inserts the silicon polymer shell rolled up, once it is in the body, he fills it with the saline liquid. The silicon gel implant is larger, so he needs a bigger opening to insert it.

"Gel implants cost more than saline and require more long term follow up," Barraza said. "Once you put in saline, you're done.

Brantley has been in plastic surgery practice for 13 years. He has been an investigator for Mentor for about 8 years.

Brantley said he implants approximately equal amounts of saline and silicon implants.

"I was involved in putting gel implants in patients for the last six to eight years, in two groups of patients, post-cancer, mastectomy reconstruction, and the second set are women who had failed saline implants," he said.

Brantley said the failed saline implant group included women who did not like the feel or look of the implant or if the implant had rippled or popped.

Brantley examined the patients every three months, six months, and then once yearly after the first year, up to five years, and reported the results to Mentor.

"Mentor flew me out to Dallas, where the production facility for their gel implants is," he said. "We toured their facility to make sure things were copasetic.

"I actually got to make some implants. It was kind of neat," Brantley said. "They have shells or molds, you dip the shell in the gel, it goes into a rack, once it is cured or dried they fill the shell with the gel itself and then they put a patch valve on it to seal it."

The controversy surrounding silicon implants made people look at the implants with a doubtful eye, he said.

"It was almost guilty until proven innocent. There are still questions that lurk in patients' minds," Brantley said. "But, almost invariably, they pick the gel implants if you hand them a gel implant and a saline implant.

"The quality of the implants we have now are much better than what we had pre-1990's."

But Barraza said patients should be aware of capsule contracture, which is the tightness formed by hard scar tissue surrounding the implant.

Saab also offered some warnings about implants.

"I did a lot of research," she said. "Be careful about who you let do it."

Saab's cousin is a nurse in Blevins' practice.

"She (cousin) had some women come in from other doctors, and it wasn't done right," Saab said. "One breast was bigger than another.

"Do major research on your doctor and get feedback before you pick somebody," she said.

Saab said she was very pleased with the doctor she chose and implant choice.

She said her implants look and feel natural.

Dr. Asim Haque, 33, a medical student and a doctor of sensory neurobiology is originally from India but now lives in Jackson. He has dealt with breast implants both medically and personally.

"Although silicone implants might feel a smidgen more real to me, knowing that the female will be safe if the saline ever leaks, makes me prefer them," Haque said. "Of course, 'au natural' is best."

There is sometimes a stigma surrounding breast implants.

"At first, I didn't want people to know," said Saab. "My grandmother said people would look down on me."

However, she is now very open about her implants. She even has answers worked out for those who question her.

"Once you buy them, they're yours, so I say they are mine," she said.

"I've always wanted to look like a Barbie doll," Saab said with a laugh. "I dress like a cute Barbie, and Barbie has breasts. I even drive a hot pink Bug, it's a Barbie car."

Saab laughed about her Barbie analogy, then seriously added, "It was painful, but worth it; I would do it again.

"I love mine (implants), it gives you a reason to go to Victoria's Secret, and I love Victoria's Secret," Saab said, laughing.

 

 


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