Implant Focus Shifts to Rarity of Implant-Related Cancer

A mix of caution, approval, and a touch of I-told-you-so greeted the FDA announcement that breast implants have been linked to a rare form of lymphoma.
In general, emphasis on the rareness of the disease and its association with breast implants predominated among physicians and surgeons familiar with the situation.
Plastic surgeons and a lymphoma specialist told MedPage Today that the 34 cases of anaplastic large-cell lymphoma (ALCL) among U.S. breast-implant users -- and about 60 cases worldwide -- are not a reason for deep or widespread concern.
Moreover, the FDA found itself on the receiving end of kudos from the medical community, as plastic surgeons applauded the agency for bringing the issue out in the open and heading off a potential flood of concern.
"I am very pleased that the FDA has brought this to light and that the plastic surgery organizations are working together with the FDA for the safety and betterment of our patients," Alan Matarasso, MD, a plastic surgeon at Lenox Hill Hospital in New York, told MedPage Today.
In an email response to MedPage Today and ABC News, Miami plastic surgeon Constantino Mendieta, MD, noted that the FDA pointed out that "ALCL associated with breast implants is extremely rate. A woman is more likely to be struck by lightning than get this condition."
However, a Detroit environmental medicine specialist said the FDA could have addressed the issue more than a decade ago -- when he petitioned government officials to examine the potential health risks of chemicals used in the manufacture of breast implants.
"I warned them that breast implants contained toxins and that there could be health problems, and they ignored me," said Michael Harbut, MD, of the Karmanos Cancer Institute.
In a 70-page petition he sent to the FDA in October 2000, Harbut called on the FDA to warn the public that medical devices containing silicone (found in the external shell of breast implants) are manufactured with the chemical catalyst hexachloroplatinate, which can trigger immunologic reactions associated with a variety of adverse health effects.
An FDA spokesperson said the agency would respond to Harbut's comments, but at deadline MedPage Today had not received the response.
The American Society of Plastic Surgeons (ASPS) announced plans to join with the FDA in establishing a breast implant registry to document adverse effects, including any additional cases of ALCL.
"At first there was no general agreement as to what constitutes this condition," said ASPS president Phillip Haeck, MD, who practices in Seattle. "It was very difficult to get all of the science put together in one place.
"The beauty of starting a registry in conjunction with the FDA is that it obviates the need to follow the HIPAA (Health Insurance Portability and Accountability Act) privacy rules. The average researcher has to use the HIPAA privacy rules and the FDA does not. The FDA will be able to gather a lot of the information that the average scientist was stumbling to put together.
"The registry will have a lot of pieces of information that just weren't available. We didn't know what to tell our patients because we just didn't know what this was. Going forward we will be able to do that."
Matarasso, Mendieta, Haeck, and other plastic surgeons responding to MedPage Today and ABC News repeatedly emphasized the rarity of ALCL and the even rarer condition of ALCL associated with breast implants.
According to National Cancer Institute data cited by the FDA, the incidence of ALCL in women is about one case per 500,000. The rate among women with breast implants is about three cases in every 100 million.
None of the 60 cases of implant-associated ALCL identified thus far proved fatal.
The implant-associated cases fall into the category known as anaplastic large-cell lymphoma kinase (ALK)-negative. Some observers have speculated that implant-related ALCL is a variant of ALK-negative disease. Houston lymphoma specialist Anas Younes, MD, acknowledged the possibility while reiterating the rarity of the condition.
"When you zoom down on just the ALK-negative cases, regardless of origin, you're talking about maybe 200 cases per year, so it is extremely rare," Younes, of the University of Texas MD Anderson Cancer Center, told MedPage Today.
Standard treatment for most patients with ALCL is CHOP chemotherapy, he added. However, most cases are in advanced stages when diagnosed.
Implant-associated ALCL tends to be confined to the capsule surrounding the implant and sometimes immediately adjacent tissue. Most cases thus far have been been managed with surgery and local therapy.