Breast Implants
Feds Urged to Continue Breast Implant Ban
WASHINGTON (Oct. 14) - Women pleaded with the government on Tuesday to continue a ban on most silicone gel breast implants, telling of years of pain and suffering they blame on leaking devices. As many as 46 percent of women who get silicone-gel breast implants need additional surgery within three years, research indicates.
Manufacturer Inamed Corp. argues that implants filled with silicone gel are comparable to today's only option, those filled with salt water _ which just as frequently require more surgery, too.
That doesn't justify letting routine sales of silicone implants resume, a line of women told advisers to the Food and Drug Administration. "I live in pain every day," said Sherry Henderson of Louisiana, who had her silicone implants removed after 11 years and cites a litany of diseases including lupus and chronic fatigue. "We are tired of all the suffering."
"My bones still scream with pain," said breast cancer survivor Pam Dowd of Boise, Idaho, who had silicone scraped off her chest wall when her leaking implants were removed in 1995. "We are being asked one more time to trust the manufacturers. ... We have no reason to believe they're telling the truth."
They spoke as the FDA's advisers began a two-day meeting to decide if Inamed has proved its case. Dozens of women are lined up for a chance to sway the decision, most of them critics.
These celebrities have had silicone implants removed because of fears over implants or changing priorities for their bodies -
Pamela Anderson - Star of Baywatch and tabloid news had implants removed in 1999.
Jenny Jones - Talk show host had implants removed after 11 years.
Loretta Lynn - Country singer had leaky implants removed after 25 years.
However, some women pleaded for access to an implant they say feels more natural.
"Unfortunately for me, I'm just a woman seeking to undergo a cosmetic procedure," said Michele Colombo, 34, charging the FDA with keeping implants away from women seeking bigger breasts as a moral judgment when cancer patients can get them in studies _ and men can get silicone testicular implants.
Elizabeth Weber of Maryland tried saline implants after cancer surgery, but they turned rock-hard, causing disabling pain. She had them replaced with silicone implants and "I felt like myself, a whole, natural and complete woman," Weber said. "My breasts felt like mine. I hope you give other women the same choice."
The FDA ended routine sales of silicone gel implants in 1992 amid fears they could break apart and cause serious disease as the silicone leaked into women's tissues. While some women seeking breast reconstruction because of cancer or other problems still could get silicone implants in strictly controlled research studies, women wanting bigger breasts have had to use saline-filled implants.
Despite thousands of lawsuits that sent one of the largest implant makers, Dow Corning, into bankruptcy, major scientific studies have never proved that silicone-gel implants cause serious diseases like lupus or cancer.
The journal of Plastic and Reconstructive Surgery published a study that for the first time tracked women whose implants had already ruptured, and then assessed them two years later. After monitoring 64 Danish women with at least one ruptured implant, the authors found no change in immunologic markers (indicators of connective tissue disease).
Silicone gel has remained legal in Europe, and Inamed says in countries where women have the option, they far prefer it to saline. The popular implants today in Europe and South America are the "third generation" devices. They have sturdy silicone gel - thick, clear gelatin - that typically keeps its shape even if torn.
But critics say studies haven't tracked women for long enough to truly exonerate silicone-gel implants, and contend that local complications like painful scarring and reoperations occur too frequently to warrant their use anyway.
FDA found one in five women who received silicone implants for breast enlargement in Inamed's study needed additional surgery within three years. That risk was even larger _ 46 percent _ for breast cancer survivors who received the implants.
Both rates are similar to reoperations seen with saline-filled implants, which the FDA allows to sell as long as women are forewarned.
Proponents had hoped the silicone implants would not cause as many return trips to the operating room. Sometimes the additional surgeries were done to treat painful scarring. In 7.5 percent of enlargement cases and a quarter of cancer survivors, implants were removed or replaced, because of pain, improper position, breakage or, sometimes, patient desire for a different size.
What about long-term effects? FDA's research suggests implants are more likely to break later, after about seven years.
While FDA agrees there's little proof that implants cause serious disorders such as lupus, agency scientists say rare diseases aren't completely ruled out. Additionally, they plan to tell the meeting, a possible increase in lung cancer and brain tumors found in a handful of studies requires more research.
FDA's advisers will issue recommendations Wednesday. The FDA isn't bound by the advice but usually follows it; it hasn't set a deadline for deciding the fate of Inamed's appeal.
Breast Implants On and Off the US Market -
In 1992, FDA commissioner pulls silicone implants off market because of safety concerns; they're available on a limited basis.
In 2003, FDA advisory panel votes to bring back silicone implants
In 2004, FDA rejects advisory panel's recommendation.
On April 12, 2005 - FDA advisory panel rejects Inamed's petition to bring them back.
On April 13, 2005 - Same panel approves Mentor's petition
It's a potentially huge market: last year, 236,000 Americans had breast enlargements, over six times more than a decade earlier.
According to the April 19, 2006 issue of the Journal of the National Cancer Institute, Swedish researchers have found no evidence relating to increased risk for women who have undergone breast enlargement surgery.