The FDA has decided to allow silicone gel-filled breast implants back on the market, lifting a 14-year ban on the devices.

Late Friday the FDA issued its statement approving the implants made by Allergan, formerly Inamed, (Irvine, California) and Mentor (Santa Barbara, California) for breast reconstruction in women of all ages; and cosmetic use of the implants in women ages 22 and older.

Both companies will be required to conduct post-approval studies following about 40,000 women for 10 years after receiving the implants.

Not surprisingly, the two California companies who make the silicone gel-filled implants were pleased by the FDA’s decision, saying it provides more options for women seeking implants.

“What this means is women in America now have options that women around the world have had for 25 years,” Caroline Van Hove, a spokeswoman for Allergan, told Medical Device Daily.

The sale of silicone gel breast implants was restricted in 1992 to women who needed them for medical reasons — for augmentation after cancer surgery, for example, or to replace a broken implant — because of safety concerns.

In April 2005 the FDA’s General and Plastic Surgery Devices advisory panel left many in the industry scratching their heads when it issued a split decision, recommending the denial of Inamed’s pre-market approval application and the approval of Mentor’s (MDD, April 15, 2005). Then, the FDA sent “approvable with conditions” letters to Allergan (then known as Inamed) and Mentor in 2005 (MDD, Sept. 23, 2005). The approvable letter stipulated a number of conditions that the manufacturers needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the U.S.

Joshua Levine, president/CEO of Mentor, told teleconference listeners Monday that “over the past 14 years we have been vigilant in our efforts to return MemoryGel implants to the U.S. market, and we are pleased to reach this important milestone and to provide women seeking breast augmentation and reconstruction with new options.”

The FDA said its decision was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, the agency inspected each company’s manufacturing facilities to determine that they comply with the FDA’s Good Manufacturing Practices.

Some of the complications of silicone gel-filled breast implants reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants, the agency said.

“[The] FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,” said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

But Kim Gandy, president of the National Organization for Women (NOW; Washington), wonders why the FDA would approve a device based on just four years of data when the manufacturers have said most implant ruptures occur seven to 10 years after the operation.

NOW is among the various advocacy groups that have blasted the FDA’s decision to approve the silicone gel-filled breast implants.

“Our primary concern is that the devices are dangerous for women, and the FDA ought to be protecting women’s health and not giving their stamp of approval to devices that are dangerous,” Gandy told MDD.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine (IOM; Washington), have found no convincing evidence that breast implants are associated with either of these diseases, the FDA said. The agency said these issues would be addressed further in the postapproval studies conducted by the companies.

“The silicone breast implant is one of the most extensively studied medical devices,” Schultz said. “We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once. This is valuable information for women who may be considering these products.”

Mandated by the FDA, the patient labeling outlines factors women should think about when considering the implants.

Some of these factors are: breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman’s breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI exams over her lifetime to determine if silent rupture has occurred.

The device labeling states that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of MRI screening over a woman’s lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.

Gandy said the agency should change the word “may” to “will.”

“The cost of MRI will exceed the cost of initial surgery, and it will not be covered by insurance,” Gandy said. Explantation, she said, also costs more than implantation because “you’ve got to mop up a mess.”

In addition to requiring each company to do a large post-approval study, the approval comes with a number of other conditions, including requiring each company to: continue its core study through 10 years; conduct a focus group study of the patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.

In reaction to some of the criticism the FDA decision has drawn, Van Hove points to Allergan’s pre-clinical and clinical data, including the 1 million women worldwide who participated in the company’s pre-clinical device testing and nearly a decade of U.S. clinical experience involving more than 80,000 women.

Furthermore, Allergen said, silicone is used safely in the body in many medical devices and products, including pacemakers, heart valves, artificial joints and baby pacifiers.

According to Allergan, today’s implants are made with a more cohesive silicone gel and have a thicker shell compared to earlier breast implant devices and the company says its silicone gel-filled implants are designed to withstand more than 25 times the force of a normal mammogram without failure.