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After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe.

“We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Dr. Maisel said.

There are risks to the implants, however, r. Maisel said, including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry.  “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” he said. 

Some patients and women’s groups who testified at the meeting disagreed. 

Diana Zuckerman, president of the National Research Center for Women and Families, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants - Johnson & Johnson and Allergan - had done a poor job of studying patients who got the implants, as the F.D.A. required them to do. 

“And without proper data, we still don’t know how safe or effective they are and whether there are certiain patients at risk for extremely negative outcomes,” Ms. Zuckerman said.

Dr. Maisel agreed that the studies conducted by the two companies had failed to follow as many patients as the agency had hoped.

One purpose of this week’s meeting was to ask the expert panel what the agency and the two companies should do about that poor follow up.  Some suggested that patients should be paid for participating; others mentioned that doctors should get some money, too.

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened.  Nearly all expressed hope that a registry could be created that would follow all breast implants patients, but such registries are expensive to maintain and complicated to create.

The committee also agreed that patients should no longer be told that they should get a magnetic resonance imaging test three years after getting implants and every two years following. 

The reason for telling patients to get M.R.I.’s is that silicone breast implants sometimes rupture without women being aware, and an M.R.I. can reveal this unseen problem.

But many patients ignore the requirements because M.R.I.’s are expensive and it is not clear what they should do when an unseen rupture is discovered; the risks associated with ruptured implants may not be greater than the risks of the operation needed to take them out. 

“F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture,” Dr. Maisel said.  “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.”

Dr. Maisel promised that the F.D.A. would study whether to follow this advice.

Television host Giuliana Rancic announced that she would undergo reconstruction immediately after she receives a double mastectomy to treat a recurrence of breast cancer.  Advances in reconstructive techniques yield more natural-looking results and high patient satisfaction, says ASPS member Dr. Eugene Elliott.  “Psychologically, patients that choose to undergo reconstruction tend to be much more positive and forward thinking, anticipating feeling and looking ‘whole’ again as an integral part of their recovery from breast cancer”, he said.

Nipped, tucked and wide awake?  - Bargain plastic surgery procedure uses only local anesthesia but can be dangerous, experts warn.        

By Sabrina Rubin Erdely        msnbc.com

Paulette Hacker couldn’t stop screaming.  Lying on her side on a gurney, wearing only a bra and panties, she felt as if she were being stabbed again and again.  In a way, she was.  Through incisions in her upper back, a stainless steel tube called a cannula was suctioning out her excess fat.

“Please stop! You’re hurting me!” she cried to her doctor.  Because although Hacker’s body was limp and her mind bleary from an unknown combination of drugs she’d been given through pills and a gas mask, the 38-year-old was awake partway through the second day of liposuction on her back, underarms, abdomen, hips and neck.  That was the whole point:  She was undergoing the new and aggressively marketed Awake cosmetic surgery, which is performed under local anesthesia. 

“You can’t scream, Paulette,” a gruff voice answered her.  Hacker hazily realized that the voice did not belong to her doctor; the man performing her operation was a stranger who Hacker would later discover was a physician’s assistant.  According to Hacker, whose experience is also detailed in a Los Angeles Superior Court complaint, she could see people coming and going into the “operating room” - more like an oversized exam room - at the Rodeo Drive office of Craig Alan Bittner, M.D., a “liposculpture” practitioner in Los Angeles. (Through his attorney, Dr. Bittner strongly denies all of Hacker’s allegations.)

“Move her into the TV room - she’s making too much noise, ” a confused and terrified Hacker heard another voice say.  Her gurney was rolled down the hall and into a second room, where she could see the assitant jab her while he watched a basketball game playing in the background on a wall-mounted television.  The volume was cranked up loud enough to drown out her cries.

After the five-hour operation, Hacker says the assitant and an office clerk yanked her to her feet and squeezed her into compression garments.  Dazed and sobbing, she struggled into her clothes and found herself face-to-face with a beaming Dr. Bittner.  The doctor gently asked  why she was crying, she says.  Then he maneuvered her beside him and told her to smile for a photo.

……to see the rest of this informative article go to….  

http://www.msnbc.msn.com/id/40950317/ns/health-womans_health/