Return of silicone implants: Safety still center of debate

Panel recommends approval, with restrictions

A Food and Drug Administration (FDA) advisory committee’s recommendation that silicone gel breast implants be returned to the United States market after an essential ban of 13 years is being met with approval from some in the medical community and dismay by others.

The FDA must approve the device’s return to the market before the silicone gel implants can again be used by most women, but one company, Mentor Corp., has already received an approvable letter, one of several intermediate steps in the FDA review process of new products. Mentor’s application to produce what it says are safer, more durable implants received a vote that it is "approvable with condition" in April.

The FDA advisory committee stated in its summary of hearings on the implants that research done by the manufacturer was convincing that only about 1.4% of the implants are likely to break in the first three years after insertion, and that evidence indicated they may last as long as 10 years.

Opponents not convinced

Breaking and leakage of silicone into the users’ bodies has been at the center of the silicone implant ban. Women whose silicone breast implants ruptured in the past have attributed myriad complaints to the release of silicone into their bodies, and some research has appeared to support those claims.

Among the complaints attributed to ruptured silicone implants are breast pain, fatigue, muscle and joint pain, hair loss, problems with balance and vision, fibromyalgia, chronic fatigue, autoimmune disorders, migraines, and thyroiditis.

Recognizing the controversial history of silicone implants, in recommending that the FDA approve the implants manufactured by Santa Barbara, CA-based Mentor, the FDA advisory panel set strict conditions for the implants’ use, including:

  • Patients will sign consent forms acknowledging they understand the risks of implants.
  • Mentor only can sell the implants to board-certified plastic surgeons. The surgeons must complete training on inserting the implants.
  • Mentor must track how patients tolerate the implants. They also must conduct formal studies on implant rupture.
  • Mentor must warn patients that because implant breaks don’t cause immediate symptoms, they should get a magnetic resonance imaging scan five years after implant insertion and every two years after that, and should consider having broken implants removed.

Also, Mentor must establish an independent data safety monitoring committee to periodically review the post-approval data collection and results.

Diana Zuckerman, PhD, president of the National Research Center for Women and Families, who has written that the devices are not proved safe, called the FDA advisors’ action "shocking."

Zuckerman cited studies by the FDA that showed "a statistically significant link" between implants and fibromyalgia and several connective tissue diseases.

Following the vote by the FDA advisors, a bipartisan group of female senators led by Sens. Dianne Feinstein (D-CA) and Olympia Snowe (R-ME) urged the FDA to consider women’s safety before the agency makes a final decision.

Cosmetic surgeons, who also perform breast implant surgery, have their own complaints about the recommendation. They are fighting the FDA panel’s requirement that only board-certified plastic surgeons be permitted to use the silicone implants.

"There haven’t been any advances on this issue [since the FDA panel’s announcement], but we are continuing to push for the FDA approving the implants so that any qualified cosmetic surgeon can perform this procedure," says Charlie Baase, spokesman for the Chicago-based American Academy of Cosmetic Surgery. Cosmetic surgeons argue that board-certified cosmetic surgeons should be considered as qualified to use the implants as board-certified plastic surgeons.

The time is right’ for return

Physicians who practice plastic surgery greeted the potential return of silicone gel implants with praise for the implants and the vetting process that preceded the FDA panel’s recommendation.

"The FDA has at last accepted what many of us in the industry have known for some time — silicone implants do not cause disease," says John A. Grossman, MD, director of Grossman Plastic Surgery in Denver. "It is true that silicone implants, as with any man-made device, can become worn and break with time, but the material inside is safe."

George Orloff, MD, chief of plastic surgery at Providence Saint Joseph Medical Center in Los Angeles, says the extensive hearings and research that have gone into getting silicone implants back on the market have benefited patients.

"I think the time is right for their return," he says. "The most important thing is this evolution in change based on the process that’s been going on a long time. The critical part is that we have heard from a lot of factions — people who are pro-implants, people who are against implants, and people are interested in making sure whatever we do is safe and in the best interest of all involved."

Because of the concerns surrounding possible health risks related to silicone implant leakage, Orloff says silicone breast implants "have become the most investigated of all the implants."

"Board certification and additional physician training as recommended by the panel can only be more beneficial to both patient and physicians," he adds.

Orloff’s patients for the last several years, both because of restrictions on silicone implants and concerns over health risks, have asked for saline implants, but the demand is there for silicone, he says.

"Patients’ usual preference is for silicone, because it looks and feels more natural," he says. "Now, as more information comes back that can’t associate any ill effects due to silicone, and companies are making them safer by using thicker shells and a different formulation of silicone inside, there is a clear demand for silicone."

With the information now available on risks and benefits of silicone implants and the improvements in design, Orloff says he would feel comfortable giving the implants to a patient who wants them and is medically appropriate for the surgery.

"And I can’t say that about all implants," he says.

Sources

  • Charlie Baase, Spokesman, American Academy of Cosmetic Surgery, 737 N. Michigan Ave., Suite 2100, Chicago, IL 60611-5405. Web site: www.cosmeticsurgery.org.
  • John Grossman, MD, President, Grossman Plastic Surgery, Denver. Phone: (303) 320-5566.
  • George Orloff, MD, Chief of Plastic Surgery, Providence Saint Joseph Medical Center, Los Angeles. Phone: (818) 848-0598.
  • Diana Zuckerman, PhD, President, National Research Center for Women and Families, Washington, DC. Phone: (202) 223-4000.
  • Mentor Corp., Santa Barbara, CA. Phone: (800) 525-0245. Web site: www.mentorcorp.com.
  • U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852. Phone: (301) 827-6500.