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Allergan, the maker of Natrelle implants, which had a 60% follow up rate with patients after two years, said they paid women a small amount of money for filling out annual questionnaires and coming back to scheduled office visits. Mentor did not.
Breast Implant Safety Studies Will Continue
"The current post approval studies will continue," said William Maisel, MD, MPH, chief scientist in the FDA's Center for Devices and Radiological Health, in remarks after the meeting. "The FDA is committed to seeing them completed and making sure the follow up rates improve."
Manufacturers RespondManufacturers fired back against the notion that they weren't doing enough to complete the studies.
In contrast to the 21% of patients retained overall by one of the Mentor studies, Hammond said he'd kept track of about 76% of the women he was following.
Additionally, "A really compelling part would be if the patient had some sort of compensation. It doesn't have to be wild, really, just something they get back to compensate for the drive in."
Ideas for Improving Study Follow UpIn other testimony, panelists heard from plastic surgeons like Dennis Hammond, MD, of Cedar Rapids, Mich., who participated in the clinical trials of Mentor's Memory Gel implants.
done much more to ensure it had the technical skills to locate women and provide women with incentives to participate in this important research."
Perspective of SurgeonsThe American Society of Plastic Surgeons (ASPS) agreed, and it urged the FDA to consider other data sources, besides the troubled studies, if the agency still felt the need for continued safety monitoring.
Save or Scrap Troubled Studies?In a second day of testimony, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to the FDA heard plenty of opinions about what should happen with the studies.
Some consumer advocates thought that option ought to be on the table, however.
Some panelists felt the companies should be compelled by the FDA to Nike Vapormax Ice Blue finish the studies they had agreed to complete as a condition of the approval of their devices. They asked FDA officials what regulatory powers Nike Vapormax Black And Gold
Aug. 31, 2011 After two days of testimony on what the FDA should do about troubled long term safety studies of silicone gel breast implants, agency officials said the studies would continue.
"It has now been 25 years since FDA declared silicone breast implants a class III device, and in that period, only weak attempts have been made to assess the safety of these implants," said Kate Ryan, of the nonprofit Breast Cancer Action, which is based in San Francisco.
"Follow up rates on the two large studies are dismal," Ryan said in testimony. "Given that these studies were a condition of approval, Mentor should have Nike Vapormax Navy
The safety studies in question, of nearly 100,000 women with breast implants, which the FDA said were the largest ever required of manufacturers after their devices were marketed to the public, have lost track of up to 79% of the women they enrolled just three years into planned 10 year efforts.
The agency said it was not considering taking silicone breast implants off the market.
"To imply that patient safety is not first on our radar is simply inaccurate," said Caroline Van Hove, a spokeswoman for Allergan. She said the company hoped that the meeting would give the FDA an opportunity to more fully appreciate the complexity of the required Nike Vapormax Strap On Feet
"While it was certainly admirable to try to get 40,000 patients [in each study] to come back, that just wasn't going to happen," Hammond said.
Panelists asked him how he did it.
"In general, we are highly committed to collecting quality data in a way that is possible for them and possible for us," she said.
"There has been shown to be no relationship between silicone breast implants and connective tissue disorders, which was the main reason these studies were agreed to on the release of these products," said Phil Haeck, MD, president of the ASPS, in testimony to the panel. "This issue has been settled with the post approval study data as it already stands now."
As a result, FDA epidemiologists testified yesterday, the studies had lost the ability to find rare complications, including connective tissue diseases, that they were designed to look for.
the agency could wield to do that. Melkerson, director of the Division of Surgical, Orthopedic and Restorative Devices at the FDA's Center for Devices and Radiological Health.
"You've got to have dedicated surgeons that are really interested in making this study work," Hammond said. He said he had one staff member devoted to follow up with women in the clinical trial and that he allocated about half a day of clinical time each week to seeing women in the study for follow up visits.
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