2 Important Articles: Dr. Zuckerman and FDA allows Mentor to remove follow up requirement

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Bravo Dr. Zuckerman!

EXCERPT: A national survey by the research center found that breastMRIs cost about $2,000 each. Insurance companies don't cover them.

" If you're going to approve an implanted device that you know is goingto break, I think that's a problem, " Zuckerman said.

" All breast implants break eventually. That's the one thing thateveryone agrees on. "

And Zuckerman said she is not convinced that silicone gel that leaksfrom implants won't cause health problems.

~~~~~~~~~~~~Silicone implants make big comebackDespite controversy, women prefer them

http://www.columbusdispatch.com/dispatch/content/local_news/stories/2007/05/06/FAKEONES.ART_ART_05-06-07_A1_SG6JSFT.html

Sunday, May 6, 2007 3:43 AM By Misti Crane

THE COLUMBUS DISPATCH After a 14-year absence fueled by lawsuits and safety concerns,silicone breast implants returned late last year and have been met

with enthusiasm in many plastic surgeons' offices.

Women undergoing their first surgeries are choosing the siliconegel-filled enhancers. Others are swapping out saline implants forsilicone.

Most doctors and patients who prefer silicone say the implant feelsmore natural. It also costs about $1,000 to $1,500 more than saline.

Cost is one thing Dr. Sullivan mentions when she tellspatients the possible downside of silicone. The others are thepsychological issues associated with the bad press silicone had for so

many years and how hard it is to detect a ruptured implant.

As many as 90 percent of her patients are choosing silicone now thatit's back, she said. And most of those who've had saline implants areswitching to silicone.

Sullivan works at the Sullivan Centre on Olentangy River Road near, where she performs about 80 breast augmentations each year.She said patients' chief frustration with saline implants is that they

break often.

She's comfortable with the safety of silicone.

But some women's health advocates question whether patients reallyknow what they're getting into, including likely follow-up surgeriesto replace ruptured implants and possible complications.

They say the U.S. Food and Drug Administration should not haveapproved silicone implants.

The breast business is big: 329,296 women underwent augmentationsurgery last year in the United States, the American Society ofPlastic Surgeons says. A decade earlier, the figure was 87,704.

When the FDA approved silicone implants in November, the decision camewith a requirement that each of the two manufacturers study about40,000 women for 10 years.

It also came with a recommendation that women have MRIs every otheryear to check for ruptures. When saline implants break, women knowright away. When silicone implants break, women and their doctors

often can't tell.

The response to silicone's return to the market has been relativelystrong but varies from region to region and practice to practice, saidDr. Greco, a spokesman for the American Society of Plastic

Surgeons.

Greco, who practices in Georgia, is like most other plastic surgeonswho are convinced silicone is safe. They say that there is no provenscientific link between the implants and problems some women have

attributed to them, including neurological problems and arthritis.

The primary risks with either type are infection, rupture and acondition called " capsular contracture, " in which hard scar tissuedevelops around the breast and tightens and squeezes it. Other

potential side effects include breast pain and changes in nipplesensation.

Neither type of implant is designed to last a lifetime.

In a four-year study by the implant maker Allergan, 41 percent of newimplant patients had a significant complication within four years.That includes 23 percent who needed another operation to fix the

problem.

In Europe and elsewhere, silicone has been available for years and isthe preferred option for most women.

Dr. Dexter Blome, who practices at the Cosmetic Surgery Center of Ohioon the Far East Side, said he reviews the ups and downs of each typeof implant.

He said silicone often works best for thin women, who have less tissueover the top of the implant. That can make ripples in saline implantsmore visible.

Dr. E. Villalobos said he has done three silicone augmentationsin his Bethel Road office. He'll be a bigger advocate of siliconeafter the manufacturers have enough women for their studies, he said.

" I think there's still quite a bit of hesitancy " about safety.

Villalobos is convinced silicone is safe but isn't pushing itstrongly. The gel implants are more expensive, require a biggerincision and come pre-filled, which makes it a little more difficult

to create symmetry in some women, he said.

The first women to have the implants have to be part of the companyresearch, too, meaning they'll have to participate in surveys, haveblood tests and undergo MRIs, he said. " It's a little bit burdensome. "

Zuckerman, president of the nonprofit National Research Centerfor Women and Families, said she's particularly concerned that fewwomen will have the recommended MRIs to look for ruptures.

A national survey by the research center found that breast MRIs costabout $2,000 each. Insurance companies don't cover them.

" If you're going to approve an implanted device that you know is goingto break, I think that's a problem, " Zuckerman said.

" All breast implants break eventually. That's the one thing thateveryone agrees on. "

And Zuckerman said she is not convinced that silicone gel that leaksfrom implants won't cause health problems.

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www.BreastImplantInfo.org Dr. Zuckerman's Website

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Note from Ilena: This " back stepping " a very dangerous " amendment. " Although, even when mandated, past Mentor studies, had as few as 5% follow-up.

Mentor Announces Amendment to Its MemoryGel Breast ImplantsPost-Approval Study Protocol

http://digital50.com/news/items/BW/2001/07/14/20070502006529/mentor-announces-amendment-to-its-memorygeltm-breast-implants-post-approval-study.html

SANTA BARBARA, Calif.-(Business Wire)-May 3, 2007 - Mentor Corporation(NYSE:MNT), a leading supplier of medical products for the globalaesthetic market, announced today that it has received approval from

the U.S. Food and Drug Administration for an amendment to theCompany's MemoryGel silicone gel-filled breast implantpost-approval study (PAS) protocol. The PAS protocol amendmentaddresses patient enrollment.

Responding to questions and feedback from a number of InstitutionalReview Boards (IRB) and physicians concerning the restriction ofpatient access to an approved device, the FDA has approved Mentor'samendment to the PAS protocol to a voluntary patient enrollmentdesign. This change will allow those patients who choose not to orcannot participate in Mentor's PAS the opportunity of selecting

Mentor's MemoryGel implants for their surgery. Mentor will continuewith the mandatory requirement for physicians by only allowing accessto Mentor's MemoryGel implants to those physicians who agree to

participate in the PAS, who have or are seeking IRB approval, and whoactively encourage their patients to participate in the PAS.

The development of both Mentor's post-approval study design as well asthe physician and patient enrollment approaches was an extremelyinvolved process that took place over many months prior to FDA's

approval of Mentor's MemoryGel breast implants, with post-approvalconditions, on November 17, 2006. The confidential nature of thisregulatory process did not permit detailed input from the clinicalcommunity regarding the PAS protocol. During the early market

introduction of the MemoryGel breast implants, Mentor has benefitedgreatly from practical feedback from physicians and IRBs alike, whichresulted in Mentor submitting a premarket approval applicationsupplement for an amendment to the PAS protocol.

As of May 2, Mentor reported that it has received IRB approvals forapproximately 2,600 participating physicians in 5,000 surgicalfacilities, with approximately another 750 physicians awaiting IRB

approval. In addition, Mentor has enrolled close to 4,000 patientsinto the PAS. Mentor is fully committed to the PAS and will continueto work closely with its physicians and with FDA to monitor thestudy's progress through to completion.