toward a safer implant?
Of course, there are many women. -
When the federal government voted in January to continue 12-year-
The old ban on implantation.
But the manufacturers have prepared a card and they plan to play it soon.
The three companies are working on a different type of silicone gel TPE implant, called the cohesive gel implant, which they say is unlikely to leak or break.
A manufacturer-Inamed --
Documents are planned to be submitted later this year seeking approval for the sale of the product.
Although it is still made of silica gel, the gel in the new implant has the consistency of gummy bear sugar;
The gel inside the traditional implant has a motoroil feel.
Even if the new implant breaks, the silicone does not leak and migrate to other areas of the body, the researchers said.
In its ruling of January, the Food and Drug Administration referred to concerns about the rupture of silicone implants and what happens when such migration occurs.
\"These cohesive gel implants make many of the issues raised by the FDA irrelevant,\" the doctor said. William P. Adams Jr.
Associate Professor of Plastic Surgery, Southwest Medical Center, University of Texas, Dallas.
He is working on the cohesive gel implant manufactured by Mentor, which may be ready for approval of the product by the end of next year.
\"There is good data on cohesive gel implants in the US and Europe, and everyone wants these implants to be approved,\" Adams said . \".
Some plastic surgeons say that cohesive gel implants are also superior to other types of implants in terms of cosmetic effects.
The doctor said: \"The patient is not satisfied with the saline implantation . \"
Grant Stevens, assistant medical director, plastic surgery, Marina del Rey.
\"They don\'t like the feeling of ripples or liquids.
But they and the FDA have some concerns about liquid silicone.
Grant added: \"The cohesive gel has a better feel and appearance, but eliminates the problem of what happens when liquid silica gel is migrated from the breast, the clinical investigator of the cohesive gel implant manufactured in Dallas-
A company called Silimed.
The appearance of cohesive gel breast implants is the latest twist in the long history of breast implants, a product that many American women are very interested in.
The first breast augmentation surgery with silicone gel was launched in the United States in 1963, but was banned in 1992, except for women who were used for clinical trials and underwent breast reconstruction surgery.
At that time, the government quoted reports that the implants sometimes became hard and could break and the gel could leak.
Some studies have shown that implants cause autoimmune diseases such as erythema and arthritis, but a 1999 report from the Institute of Medicine found no connection between implants and these diseases.
After years of ongoing safety research, a split government advisory panel last year suggested that the FDA allow implants to be re-marketed for general use.
The team cited studies showing that the implants did not appear to cause an autoimmune disease, but experts advised doctors to provide patients with more information about possible complications of the implants.
However, on January, the FDA decided to continue the ban, saying the manufacturer did not answer the question of why the implant was cracked and where the gel would go when the implant leaked.
Saline implants are still available to American women (
Silicone implants under FDA restrictions)--
And they seem to do so in the recorded numbers.
According to the American Association of Plastic Surgeons, more than 254,000 women underwent breast implants in 2003, an increase of 20% over 2000.
Elsewhere in the world, women rarely choose saline implants and are increasingly choosing cohesive gel implants instead of free --
Mobile silicone implants, Stevens said.
The cohesive gel implant currently under investigation is similar to the original implant decades ago, Dr.
Rod rosridge, president of the American Association of Plastic Surgeons, chairman of plastic surgery, Southwest Medical Center, University of Texas.
\"When the implants first came out, they were like this,\" Rohrich said . \".
\"But the demand is to make the implants softer, so they add more oil.
Now we use silicone implants to achieve a complete cycle.
\"One of the criticisms of cohesive gel implants is that for some women they may be too stiff.
In addition, because the implants are not very flexible, surgeons may need to make a slightly larger incision to put the implants into the breast, Adams said.
Experts pointed out that other types of implants sometimes have bag shrinkage, and bag shrinkage may also occur with cohesive gel implants.
In this case, scar tissue is formed around the implant, making the breast feel hard.
Adams added that, according to the study to date, even if silicone leaks from cohesive gel implants, although unlikely, it cannot be ruled out.
\"There is no way now to scientifically say that the cohesive gel will not leak,\" he said . \".
\"We only have two to three years of data.
We have 10 years of data in Europe and Brazil.
There are amazing results.
Patients are happier and have fewer complications.
But you needstudy]
Implant for up to 15 to 20 years to see what happens when the enclosure loses integrity.
\"Lack of long time
Some consumer activists are concerned about terminology data. \"Without long-
In terms of research, we don\'t know if this cohesive gel is better than before, \"said Sybil niedon gordrich, executive director of the command Trust Network, a consumer group critical of implant safety.
Even hard silicone can break down and migrate, she said.
Goldrich and other consumer activists continue to question the overall safety of any type of silicone implant, noting that a recent study found a high concentration of platinum in female samples receiving silicone implants.
Platinum can cause nerve damage.
A harder gel implant could cover up a breast X-ray, she said.
However, Adams said that the study of women with implants found that breast tumors could still be detected by breast X-rays, although more breast photos may need to be taken.
He added that this should not change just because the silicone gel is thicker.
Implant manufacturers are likely to seek FDA approval for cohesive gel implants and traditional liquid silicone implants;
Experts say implant manufacturers say they are working with the FDA to address the agency\'s problems with traditional silicone gel implants.
But which type of implant might be approved first-or ever --is guesswork.
\"The whole issue is politicized,\" Stevens said . \". \"It\'s absurd.
We are the only industrialized country in the world to suspend silicone gel breast augmentation.