Implant manufacturer Inamed corporation has filed an application with the FDA to put its silicone gel-filled breast implants back on the market in the U.S. and will present new information on the safety of the devices to an FDA advisory panel on Oct. 14 and 15.
Concerns about potential health risks associated with the use of silicone breast implants prompted the FDA to ban the implants in 1992 until more data became available on the long-term effects of the devices.
"There is so much more information available today than there was in the early 1990s," says JoAnn Khune, Inamed's senior director of regulatory and clinical affairs. "A great body of evidence now shows that there is no link between silicone breast implants and any type of systemic disease."
Inamed's own study on silicone breast implants as well as other research to be presented at the meeting was released on the FDA web site Friday. But women's health advocates say they still aren't convinced that the devices are safe.
"Now that I've seen the data, I can't imagine how they could approve them under these conditions," says Diana Zuckerman, PhD, president of the National Center for Policy Research for Women & Families.
In fact, several public interest groups have joined together to launch a media campaign highlighting both the known and unknown dangers of silicone breast implants in response to Inamed's application. These groups include the National Organization of Women, Public Citizen, and Command Trust Network.
The groups argue that too little is known about the risks associated with silicone breast implants, and short-term studies are not adequate enough to test the safety of long-term devices.
Silicone Implants and the FDA
Silicone gel-filled breast implants were introduced in the U.S. in the early 1960s, before medical devices became subject to FDA regulation in 1976.
By the early 1990s concerns about potential health risks associated with silicone breast implants began to emerge, including leakage and rupture problems, reports of connective tissue disorders, and a possible cancer risk among women with the implants.
These concerns caused the FDA to ban the sale of silicone breast implants in 1992, except for use in clinical trials. The ban also prompted a string of lawsuits against implant manufacturers from women who said they suffered health problems or disfiguration as a result of their silicone breast implants.
In December 2002, Inamed filed a product marketing application with the FDA for a silicone implant based on the results of their own study of 1,000 women with the implants who were followed for at least three years as well as other research published since the ban was enacted.
Inamed's competitor, Mentor, says it plans a similar filing later this year for its silicone breast implant.
Assessing the Risks
In 1999, a report from the Institute of Medicine stated that women with silicone breast implants are no more likely to develop life-threatening illnesses, but it's clear that they can cause serious problems.
Researchers found that the most serious complications associated with silicone breast implants occur when the tissue around them contracts, when the implant ruptures, or when infection occurs. The risk of these problems increases with time. Studies have shown that about 26% of silicone implants rupture after 12 years and 55% after about 16 years.
"As with any type of implant or medical device, there are going to be local complications, and breast implants are no different," Khune tells WebMD. "No implant is risk free, and no device can claim to last forever."
Research submitted to the FDA by Inamed shows that most implant ruptures were revealed by MRI screening conducted as a part of its clinical trial. But experts are concerned that these "silent ruptures" may go undetected for years and cause serious problems or deformities in women without adequate screening procedures in place for all women with silicone implants.
Zuckerman says that silicone gel eventually starts to break down and when it leaks and spreads into the body, it causes lumps under the skin that can be a real mess to clean up surgically.
"When you try to remove a broken and leaking implant, you often find the only way to get it out is to take breast tissue and other things along with it and you end up with an expense and difficult six-hour operation costing up to $20,000, none of which is covered by insurance," says Zuckerman.
Other potential health effects associated with implants to be discussed at the meeting include:
- Cancer risk. Studies have not found an increased risk of breast cancer among women with silicone breast implants, but higher rates of other cancers, such as lung, cervical, vulvar, and leukemia have been reported.
- Mammography difficulties. Implants may make some breast cancers harder to detect or cause pain, rupture, and leakage during mammography, but the research is not consistent on this issue.
- Connective tissue disorders. Current research does not support a link between silicone breast implants and connective tissue disorders (such as rheumatoid arthritis and fibromyalgia) but it does not completely address rare forms of these forms of disease.
- Interference with breastfeeding. Although no study has shown a difference in the quality of breast milk from women with breast implants, women with implants are less likely to successfully breast feed an infant.
- Reproductive issues. Researchers say current evidence is not sufficient to rule out a rare or subtle effect on children of women with silicone implants. Isolated cases of immune disorders in children have been reported, but the findings have not been confirmed.
- Suicide risk. Some studies have noted a slightly higher suicide risk among breast implant recipients. But overall, research has shown that breast implant patients are healthier than their peers and do not have higher death rates compared with other women.
In addition, Zuckerman says she's also concerned about the results of the Inamed study that showed women's overall general and mental health worsened two years after getting silicone breast implants.
Silicone vs. Saline
Meanwhile, saline-filled breast implants are already approved for use in breast augmentation and reconstruction surgery. These implants contain a saltwater saline solution similar to that used in IV fluids.
Although saline implants are also likely to leak or rupture over time, research shows that the risks posed by leakage are less serious because the body readily absorbs the saline solution.
But some plastic surgeons say many women would still prefer a choice.
James Wells, MD, president of the American Academy of Plastic Surgeons, says that in other areas of the world where the use of silicone implants is not restricted, about 90% of women select silicone gel breast implants over saline for aesthetic reasons.
"The gel is more natural in terms of the consistency of the breast," says Wells, "and the saline is a little bit more like a water balloon."
Booming Market for Breast Implants
Despite the uncertainty about breast implants, the demand for them is clearly increasing.
According to the American Society of Plastic Surgeons, more than 225,000 women received breast implants for cosmetic reasons in 2002, a 593% increase since 1992. Breast augmentation was also among the top 5 cosmetic plastic surgery procedures in 2002.
Wells says that most women are satisfied with the results of their breast implant surgery and are informed about the potential risks before undergoing the procedure.
"Silicone has been around 30 years so the chemistry and safety of silicone is pretty well acknowledged," Wells tells WebMD. "What you're really looking at are local mechanical problems of the device, which like any man-made device will eventually wear out and have to be replaced."
But Zuckerkman says that if the FDA approves products such as silicone breast implants that have such a high complication rate, the manufacturers will have no incentive to improve the safety of the devices.
The panel will also hear public comment on the issue during its meeting this week before making its recommendation to the agency. The FDA is not required to follow the panel's recommendation, but it usually does.