Medical Device Daily Washington Editor
GAITHERSBURG, Maryland – For the second time in less than two years, the FDA is debating silicone-gel breast implants. In this second go-round, the FDA heard much the same testimony for and against.
The General and Plastic Surgery Devices Panel of the FDA's Center for Devices and Radiological Health yesterday began the first of three days of testimony to make a recommendation on whether the devices are safe enough to be widely marketed. The implants are available in many other countries.
Monday's meeting was devoted to hearing open public testimony. The panel scheduled more than 12 hours to listen to impassioned pleas from both sides of the debate.
Those testifying against approval of the implants charged that the devices cause a wide variety of ailments, including cancer and a range of connective tissue disorders, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma and Sj gren's syndrome.
Others complained of painful scarring, scars that are slow to heal or implants that ruptured after a short period of time.
Some of those testifying described losing mobility, increased fatigue, job loss, mental disorders and suicide.
"They [silicone implants] poisoned my mother," Brenna Dowd of Boise, Idaho, told the panel, choking back tears. "I have never known a healthy mother."
Dowd described how it is difficult for her mother to walk, saying that she often crawls due to the pain.
Susan Helman of Florida testified that she suffered from headaches and nausea after platinum from her gel implants leaked. "I don't want anyone else to suffer this way," she told the panel members.
For supporters of the devices, the implants represent making an educated choice, whether as a cancer patient looking for reconstructive surgery or for women opting for an elective procedure to alter their appearance.
John Baeke, a plastic surgeon from Kansas City, Kansas, and clinical instructor at the University of Kansas School of Medicine, told the panel that women who elect to have breast enhancement are too often categorized as "bimbos."
"Shame on you," he said. "The cosmetic patient is typically careered, in her 30s, seeks multiple opinions and is well-versed on the subject."
Lorraine Tafra, MD, a breast surgeon and director of the Anne Arundel Medical Center Breast Center (Annapolis, Maryland), told the panel that decisions that limit patient options must be made on the basis of solid scientific evidence and not politics.
"Breast implants should be regarded as any other medical device that is considered by this panel," she said. "Further, distinctions should not be made between their use for reconstruction or augmentation purposes."
She added, rhetorically: "What kind of message does this send out to breast cancer patients?"
Tafra said she welcomed the FDA's review of new safety data.
Michele Colombo from Lake Worth, Florida, told Medical Device Daily following her testimony that women should be able to make informed decisions based on scientific data.
Colombo received her elective implants in January 2004 as part of a recent clinical trial.
"I have done so much research on this issue, and I don't worry about leakage," she said, though she is aware that the implants may have to be replaced later in life.
"This is not a moral issue. It is a scientific issue and one of personal choice. I can make that decision for myself," she told MDD.
On Tuesday the panel will consider and vote on a premarket approval (PMA) application from Inamed (Santa Barbara, California).
Wednesday's meeting will focus on a PMA application from Mentor (also Santa Barbara).
Since 1992 in the U.S., silicone breast implants have been limited to patients seeking reconstruction surgery following breast cancer, restricting their use based on safety concerns. The patients who undergo breast augmentation surgery are currently limited to saline implants.
Much of the debate has been focused on the availability of long-term data demonstrating whether the implants are – or are not – associated with autoimmune disorders and other adverse effects that have been claimed by many women.
In October 2003 the panel narrowly recommended Ina-med's product for approval, but the FDA rejected the panel's recommendation in early 2004.
The FDA has been particularly interested in breakage data. Last week, the agency released its review of some of the data contained in the companies' applications, and said it would be "difficult to reasonably predict the probability of rupture through year 10 with the available data."
The FDA also expressed concern that studies followed a small number of patients for a short period of time.
Inamed and Mentor submitted data to the FDA suggesting that in three to four years, about 1% to 20% of implants rupture, requiring additional surgery to remove or replace them. Both companies, however, have said that modern implants are stronger than models produced in the 1970s and 1980s.
"This meeting is not intended as a general referendum on silicone breast implants," Miriam Provost, acting director for the FDA's device evaluation division, reminded panel members, company representatives and the pubic. "We will make our decision based on the scientific data."
According to the American Society of Plastic Surgeons (Arlington Heights, Illinois), more than 264,000 cosmetic implant procedures and nearly 63,000 breast reconstructions were performed in 2004.