Breast Implants Persuasive Speech
Friday, 19 May, 2000, 10:13 GMT 11:13 UK
Huge rupture rate in breast implants
Many of the inplants had ruptured
Almost seven out of ten silicone-gel breast implants scanned by researchers had developed a leak.
The US Food and Drug Administration (FDA) study could reawaken the debate over the safety of breast implants.
Many women claim that leaking silicone-gel has sparked serious illness, including chronic autoimmune disease.
The FDA team used MRI scans too look at 344 women with implants.
They found that 69% had a least one ruptured implant.
And in 21%, the silicone gel contained within the implant had leaked beyond the breast into other parts of the body.
In another part of the study, 907 women who had undergone …show more content…
The larger issue, she says, is the local complications that are clearly related to breast implants, such as rupture and migration of the silicone gel, capsular contracture, and infection.
"Of the two groups of women who consider getting implants--for breast reconstruction or for augmentation," Brown says, "the larger group wants them for cosmetic purposes. These are healthy women who may go out and get implants without a clear picture of what the possible risks are. They may end up going back in for surgery time and again and never be happy with the cosmetic effect."
In testimony before a congressional subcommittee in August 1995, FDA Commissioner David A. Kessler, M.D., stated that "Published studies to date suggest a rupture rate between 5 and 51 percent--an enormous range--and, unfortunately, we do not know with any confidence where within that range the real rupture rate lies." He also cited two studies that indicate the risk of rupture increases as the implants …show more content…
When the Medical Device Amendments were passed, it was determined that these devices would also eventually require premarket approval. In January 1993, FDA notified saline implant manufacturers that they would have to submit safety and effectiveness data for their products. In December 1994, the agency told them what type of safety and effectiveness data were needed, and delineated objectives and time frames for the trials. Saline implants will stay on the market while the studies are conducted, but the companies must report the laboratory, animal and clinical data in stages, and must provide written information on the known and possible risks of their
Huge rupture rate in breast implants
Many of the inplants had ruptured
Almost seven out of ten silicone-gel breast implants scanned by researchers had developed a leak.
The US Food and Drug Administration (FDA) study could reawaken the debate over the safety of breast implants.
Many women claim that leaking silicone-gel has sparked serious illness, including chronic autoimmune disease.
The FDA team used MRI scans too look at 344 women with implants.
They found that 69% had a least one ruptured implant.
And in 21%, the silicone gel contained within the implant had leaked beyond the breast into other parts of the body.
In another part of the study, 907 women who had undergone …show more content…
The larger issue, she says, is the local complications that are clearly related to breast implants, such as rupture and migration of the silicone gel, capsular contracture, and infection.
"Of the two groups of women who consider getting implants--for breast reconstruction or for augmentation," Brown says, "the larger group wants them for cosmetic purposes. These are healthy women who may go out and get implants without a clear picture of what the possible risks are. They may end up going back in for surgery time and again and never be happy with the cosmetic effect."
In testimony before a congressional subcommittee in August 1995, FDA Commissioner David A. Kessler, M.D., stated that "Published studies to date suggest a rupture rate between 5 and 51 percent--an enormous range--and, unfortunately, we do not know with any confidence where within that range the real rupture rate lies." He also cited two studies that indicate the risk of rupture increases as the implants …show more content…
When the Medical Device Amendments were passed, it was determined that these devices would also eventually require premarket approval. In January 1993, FDA notified saline implant manufacturers that they would have to submit safety and effectiveness data for their products. In December 1994, the agency told them what type of safety and effectiveness data were needed, and delineated objectives and time frames for the trials. Saline implants will stay on the market while the studies are conducted, but the companies must report the laboratory, animal and clinical data in stages, and must provide written information on the known and possible risks of their