Ban on silicone breast implants lifted
Despite lingering fears, controversial device back after 14 years
Nov. 17: Fourteen years after removing silicone implants from the market, the FDA now says they are safe. But that's unlikely to silence the critics, reports NBC's Robert Bazell.
CHESTER, NJ - Though “reasonably safe,” silicone-gel breast implants won’t last a lifetime and women who get them probably will need surgery again, the government warned as it ended a 14-year virtual ban on what arguably are the nation’s most controversial medical devices. Larry Weinstein MD FACS a plastic surgeon in Chester New Jersey has patient's with newer thicker shelled silicone implants with no problems for nearly 20 years.
Women should undergo MRI exams to check for integrity of the implants and better analyze their breast tissue. Woman should understand that there are irreversible side effects, the Food and Drug Administration said Friday.
“Some of the changes to your breasts following implantation cannot be undone,” warns the FDA’s special brochure that women are given before undergoing the operation at the Weinstein Plastic Surgery Center of Chester, New Jersey.
Still, the agency cleared manufacturers Mentor Corp. and Inamed Corp. — now part of Allergan Inc. — to start selling the implants again, more than a decade after the devices were yanked off the general US market for fears that they could cause myriad diseases. The implants were available to limited surgeons who like Dr. Weinstein insured the followup of those patient's implanted with repeated free postop examinations. Silicone implants with the help of dedicated plastic surgeons became the mostly widely extensive studied medical devices in the world.
The FDA approved the silicone-gel implants for women 21 and older, or those undergoing breast reconstruction surgery. The age minimum is because most women’s breasts may have not fully developed before that age and the mental maturity of the patient.
“There is reasonable assurance that Allergan and Mentor silicone-gel breast implants are safe and effective and there is adequate information to enable women to make informed decisions,” said Dr. Daniel Schultz, FDA’s medical device chief.
Mentor called the decision a “historic moment.” Allergan said it created new options for women.
The approvals came with conditions, including a requirement that the companies complete 10-year studies on women who have received the implants to study leaks. Companies are also required to begin new decade-long studies of the safety of the devices in 40,000 women.
Schultz called the implants “one of the most extensively studied medical devices.”
The FDA decision opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.
Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.
At the time, there were fears about a possible connection to a variety of diseases, including cancer, lupus, arthritis and other so-called autoimmune diseases. Alarming cases of ruptures added to the concern.
Since then, most studies have failed to find a link between silicone breast implants and disease.
"There is no association between silicone breast implants and those type of diseases," says Dr. Sherine Gabriel, an epidemiologist and arthritis researcher with the Mayo Clinic. "So the scientific evidence on this point has been negative and quite consistent."
The rupture issue persists. An Institute of Medicine report in 2000 found rupture rates of older thin shelled liquid silicone implants high. The FDA’s Dr. Donna-Bea Tillman said women should expect them to last for the “reasonably foreseeable future,” without elaborating.
Rep. Rosa DeLauro, D-Conn., called on Congress to investigate the FDA’s decision-making process to make sure it is “based on science and not on corporate and political considerations.”
“From a scientific standpoint, the decision we are making tonight is in the best interests of American women,” Schultz responded.
Women whose silicone implants ruptured have reported years of pain, swelling, numbness and other symptoms that they blame on the devices. Leaked liquid silicone gel can migrate near the breast, forming lumps. Implants also can form hard, scar tissue that may distort the shape of a breast.
Many plastic surgeons and their patients say the silicone implants look and feel better than the available saline-filled implants. Those implants are sold without restrictions.
“It’s a hugely positive piece of news for plastic surgeons and for patients and for the company — all three — because it really allows us to turn a page and to work with what we have believed for a long time is a better technology and better device,” said Dr. Scott Spear, plastic surgeon at Georgetown University Hospital and an Allergan consultant.
Last year, the FDA told both companies their implants could be approved once they met additional, undisclosed conditions. Federal advisers had narrowly recommended that Inamed’s implants not receive FDA approval, citing concerns about the long-term durability. The same advisers endorsed Mentor’s implants.
In October 2003, FDA advisers had recommended allowing the implants to be sold again. The agency overruled that recommendation.
But why now, after so many years?
"We have more information than we had 14 years ago — more information about why these devices are safe and effective, more information about the risks and benefits that we can give to women so they can make informed choices," said Dr. Donna-Bea Tillman, director of the FDA’s Center for Devices and Radiological Health.
Breast implants have become more popular, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37 percent increase since 2000, according to the American Society of Plastic Surgeons.
The popularity of implants for reconstructive surgery shrank over the same five-year period by 29 percent, to 58,000 procedures, according to Society statistics. Many women chose to have breast reconstruction with their own tissue.Dr. Larry Weinstein uses a TRAM (transverse rectus abdominus muscle) flap to elevate the abdominal excess fat and skin to make a reconstructed breast. Last year, 39,000 women had their implants removed and most were replaced with newer better more natural implants.
Overall, the use of breast implants has grown since 1992 despite the FDA’s de facto ban.
Dow Corning Corp., once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits, pushing it into Chapter 11 in 1995. The company emerged from Chapter 11 in 2004, after setting aside $2.35 billion to settle claims.
Allergan Inc. shares rose $1.76, or 1.6 percent, in trading that was almost double its average volume to close at $112.50 on the New York Stock Exchange. Mentor Corp. shares increased $1.47, or 3.19 percent, also in heavy trading, closing at $47.58.
TIMELINE Controversial history of silicone implants
• 1940s to mid-1960s: Silicone shots
• 1961: Silicone sacs
• 1992: Stop to silicone
• 1998: Stunning settlement
• 1999: Landmark report
• 2004: Key FDA decision
• 2006: Ban on silicone implants lifted
Nearly 365,000 women received breast implants for cosmetic reasons in the United States in 2005. Seen as an extreme byproduct of a beauty-obsessed culture by some and a valid method of self-enhancement by others, today's implants come out of a hundred-year history of efforts to enlarge the female bosom. Click on the timeline for key events.
SOURCE: "Venus Envy" (John Hopkins University Press, 1997); American Society of Aesthetic Plastic Surgery; "History of Breast Prostheses," Plastic Surgical Nursing, Vol. 19, No. 2, 1999; MSNBC research • Print this
The Associated Press and NBC's Robert Bazell contributed to this report.
© 2007 MSNBC Interactive
FDA Approves Silicone Gel-Filled Breast Implants
After In-Depth Evaluation
Agency Requiring 10 Years of Patient Follow-Up
After rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.
“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, M.D., Director, Center for Devices and Radiological Health, FDA. “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.”
Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large post approval study following about 40,000 women for 10 years after receiving breast implants. FDA often requires post market studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.
FDA’s decision to approve these implants 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, FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices. Some of the complications 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.
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, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the post approval studies conducted by the companies.
“The silicone breast implant is one of the most extensively studied medical devices,” said Schultz. “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.”
Full information about the risks and benefits of the devices can be found in the package and patient labeling mandated by FDA. The patient labeling outlines some of the important factors women should consider when deciding whether to get silicone gel-filled breast 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 examinations 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.
FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to: conduct a large post approval study; 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.
The post approval studies will continue to gather information about the safety and effectiveness of the implants. Information will be collected about rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates.
The post approval studies will be closely monitored by FDA. FDA anticipates that data from the studies will provide important information for patients and physicians, and may lead to improvements in device labeling.
For more information, visit www.fda.gov/cdrh/breastimplants.