This Just in - What a Relief!
Breast Implants Back
On Canadian Market
A WALL STREET JOURNAL NEWS ROUNDUP
October 21, 2006 12:34 a.m.
The Canadian government Friday licensed the sale of silicone gel breast implants, reversing a partial ban that was in place for more than 13 years over health concerns.
While Irvine, Calif.-based Allergan Inc. was granted a medical device license to market its Inamed silicone-filled breast implants, Santa Barbara, Calif.-based Mentor Corp. received a license for its silicone MemoryGel breast implants. Both licenses are subject to certain conditions, Health Canada said.
Until now, only saline-filled breast implants have been licensed for sale in the Canada.
Mentor said the license will allow it to sell the implants for use in augmentation, reconstruction and revision procedures.
The terms and conditions both companies must meet include updates of long-term clinical trials, patient focus groups in Canada, a long-term study involving tens of thousands of women, a survey of Canadian plastic surgeons on labeling and brochures, and implant retrieval and analysis studies, Health Canada said.
The companies also must provide updated sales and marketing histories, including any reported problems or recalls, and provide implant registration cards, the agency said.
On Canadian Market
A WALL STREET JOURNAL NEWS ROUNDUP
October 21, 2006 12:34 a.m.
The Canadian government Friday licensed the sale of silicone gel breast implants, reversing a partial ban that was in place for more than 13 years over health concerns.
While Irvine, Calif.-based Allergan Inc. was granted a medical device license to market its Inamed silicone-filled breast implants, Santa Barbara, Calif.-based Mentor Corp. received a license for its silicone MemoryGel breast implants. Both licenses are subject to certain conditions, Health Canada said.
Until now, only saline-filled breast implants have been licensed for sale in the Canada.
Mentor said the license will allow it to sell the implants for use in augmentation, reconstruction and revision procedures.
The terms and conditions both companies must meet include updates of long-term clinical trials, patient focus groups in Canada, a long-term study involving tens of thousands of women, a survey of Canadian plastic surgeons on labeling and brochures, and implant retrieval and analysis studies, Health Canada said.
The companies also must provide updated sales and marketing histories, including any reported problems or recalls, and provide implant registration cards, the agency said.
posted by divadab | 09:56
0 Comments:
Post a Comment
<< Home