Account Minecraft Free Mc Premium Org
4 years ago
Big, Bigger, Biggest , Huge
The wait is over. Women who want silicone breast implants can now have them -- thanks to the lifting of a 14-year ban by the U.S. Food and Drug Administration.
The implants were taken off the market in 1992 after some women complained that they leaked silicone into their bodies and caused serious health problems. Several extensive studies have since been conducted in and outside the United States, and some doctors say claims the implants are harmful have not been proven.
"Essentially, they found through fairly exhaustive studies that the new generation silicone implants are safe for people," said Dr. Peter Butler, a plastic surgeon with Gulf Coast Plastic Surgery in Gulf Breeze. "The main factor is that leaking does not cause tissue problems —— simply put, we don't want silicone leaking into our systems."
When the implants were taken off the market, women were concerned that leaking silicon implants were causing a number of diseases. At the time, the doctors said, there was no research to disprove the claims. But new studies have found that the gel implants are much more cohesive and are safe for use.
"When you have surgery, you lose a lot of breast volume," said Carlo, a registered nurse. "I knew the silicone implants were more natural feeling and looking. I feel comfortable making the decision to have them."
Still, the FDA will continue to monitor the products and is requiring each company to conduct follow-up studies. Both companies are expected to track about 40,000 women for 10 years after they receive implants. The agency said package labeling should alert women who opt for the silicone implant to consider these factors as well:
· Breast implants are not lifetime devices, and a woman will likely need additional surgeries on her breast at least once over her lifetime.
· Many of the changes to a woman's breast following implementation are irreversible.
· Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.
· A woman will need regular screening MRI (magnetic resonance imaging) exams over her lifetime to determine if a rupture has occurred; a woman should have her first MRI three years after the initial implant surgery and every two years thereafter. The cost of MRI screening over a women's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. And if the implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information, to determine the benefits and risks of these products," said Dr. Daniel Schultz, FDA director, Center for Devices and Radiological Health. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
The implants were taken off the market in 1992 after some women complained that they leaked silicone into their bodies and caused serious health problems. Several extensive studies have since been conducted in and outside the United States, and some doctors say claims the implants are harmful have not been proven.
"Essentially, they found through fairly exhaustive studies that the new generation silicone implants are safe for people," said Dr. Peter Butler, a plastic surgeon with Gulf Coast Plastic Surgery in Gulf Breeze. "The main factor is that leaking does not cause tissue problems —— simply put, we don't want silicone leaking into our systems."
When the implants were taken off the market, women were concerned that leaking silicon implants were causing a number of diseases. At the time, the doctors said, there was no research to disprove the claims. But new studies have found that the gel implants are much more cohesive and are safe for use.
"When you have surgery, you lose a lot of breast volume," said Carlo, a registered nurse. "I knew the silicone implants were more natural feeling and looking. I feel comfortable making the decision to have them."
Still, the FDA will continue to monitor the products and is requiring each company to conduct follow-up studies. Both companies are expected to track about 40,000 women for 10 years after they receive implants. The agency said package labeling should alert women who opt for the silicone implant to consider these factors as well:
· Breast implants are not lifetime devices, and a woman will likely need additional surgeries on her breast at least once over her lifetime.
· Many of the changes to a woman's breast following implementation are irreversible.
· Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.
· A woman will need regular screening MRI (magnetic resonance imaging) exams over her lifetime to determine if a rupture has occurred; a woman should have her first MRI three years after the initial implant surgery and every two years thereafter. The cost of MRI screening over a women's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. And if the implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information, to determine the benefits and risks of these products," said Dr. Daniel Schultz, FDA director, Center for Devices and Radiological Health. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
I would like to see the studies where the FDA stated implants were safe for use?
First of all they did not say that at all, what they did state is that these moron Doctors and manufacturers are allowed to use women for another 10 years to conduct studies, that women will need to get an MRI every two years at there own expense to see if they are leaking or ruptured.
Also the core studies of the manufucturers do not show that the new cohesive gel implants are safe from leakage, they do rupture they do leak. Check out the FDA site for adverse event reports on the breast implants.
They did not state in this article posting that was made that they still have a complication with re-operations being performed due to complications.
They did very little studies on cancer patients with implant reconstruction it was to small and very few women were used.
The studies that the people like to refer to as proving implants are safe, are seriously flawed the mayo, harvard nurses,and IOM studies are well documented for the flaws.
They paid Scientists to do the studies who had a major conflict as they made it appear they were safe. Dow was involved in funding these studies so stand back for one minute and think about whether they would of allowed the truth out.
The plastic surgeons have a huge financial vested interest in these being approved they make a lot of money in a year implanting women then dumping them when they have complications.
I would like to see the Doctor in this post sign a waiver that he will be responsible for any woman who has problems and I want especially to see them sign a waiver saying they are safe including Mentor and Inamed! Instead of the women having to sign waivers they won't sue!!!!
Sandra L
--------------------------------------------------------------------------------
The "Harvard Nurses Study," officially titled Silicone Breast Implants and Connective Tissue Disease, was conducted by researchers at Harvard Medical School, the Harvard School of Public Health, and Brigham and Women's Hospital in Boston. The study, first presented at the October 1994 meeting of the American College of Rheumatology and published June 22, 1995 in The New England Journal of Medicine, claims that there is no association between silicone breast implants and connective tissue disease.
This study is seriously flawed and raises serious ethical issues:
Two of the authors of the study, Dr. Graham A. Colditz and Dr. Matthew H. Liang, admitted under threat of perjury that they were paid consultants of breast implant manufacturers.
Dr. Colditz admitted under oath that he knew Dow Corning had donated $5 million to Brigham Women's Hospital.
Inappropriate scientific methodology was used. The information was gathered from questionnaires and conclusions were based on follow-up medical records. The women in the study were never examined by the researchers.
The number of women in the study was too small and the time period too short. Of the 87,501 women studied, only 1,183 women had breast implants. The study included women who had intact, as opposed to ruptured, implants, as well as women who had had implants for as little as one month. By including women with such recent implants, the study erroneously concluded that the women would not become sick. Experts have determined that the latency period for connective-tissue disease is between 8 and 15 years after implantation.
Conclusions about silicone poisoning were based on "classic auto-immune diseases" and symptoms. But silicone poisoning is a new disease, which does not show "classic" autoimmune symptoms.
The National Cancer Institute and the National Institute of Health held a symposium in March 1995 on "The Immunology of Silicone," to discuss recent evidence of high cancer rates in women with silicone breast implants. Experts at the symposium concluded that exposure to silicone mammary implants sets into motion significant and long-lasting diseases with many immunopathic findings.
There is a demonstrated association between silicone from breast implants and connective tissue disease. The silicone stimulates the immune system, causing the body to attack itself.
These diseases include lupus (persistent ulcerous lesions that spread over the skin); scleroderma (an autoimmune disease causing hardening of blood vessels and connective tissue); Sjogren's disease (dryness in the eyes, mouth, nose, vagina); neurological problems such as numbness or tingling in the joints; problems with vision and hearing; silicone poisoning can also cause a fibrotic condition in the lungs which can lead to suffocation.
Even the authors of the Harvard study admitted, "...the study cannot be considered definitively negative" regarding the link between silicone and connective-tissue diseases.
While the Harvard study claims to support the findings of a previous pro-breast implant report by the Mayo Clinic, the Harvard study's flaws are similar to the flaws in the Mayo Clinic study which examined a small group of women in a single area of Minnesota over a brief period of time, with no follow-up research performed. In addition,
The Mayo Clinic study was partially funded by the American Society of Plastic and Reconstructive Surgeons.
The authors of the Mayo Clinic study themselves admit: "...our study has several limitations...Our results, therefore, cannot be considered definitive proof of the absence of an association between breast implants and connective-tissue disease." (New England Journal of Medicine, 6/16/94) http://consumerlawpage.com/article/breast.shtml