Allergan Inc. and Johnson & Johnson breast implants were linked in a U.S. review to a rare type of cancer, challenging again the safety of the decades-old products.
About 60 cases of anaplastic large-cell lymphoma have been reported globally in women with breast implants, including 34 published in studies from January 1997 to May 2010, the Food and Drug Administration said today in a notice. Doctors should consider the possibility of cancer in patients with late onset symptoms, including pain, lumps or swelling, the FDA said.
The FDA isn’t recommending that women with implants adjust their medical care. The number of cases is small compared with the estimated 5 million to 10 million women around the world who have received breast implants, the agency said. The announcement isn’t likely to “impact implant use in any meaningful way,” said Gary Nachman, an analyst at Susquehanna Financial Group.
“Whenever you have the word ‘cancer’ associated with a product, people are going to take pause,” Nachman said today in a telephone interview from New York. “Absolutely patients have to think about it, but in the end I don’t think it’s going to make or break the decision for most people to get implants.”
Allergan, the Irvine, California-based maker of Natrelle gel and saline breast implants, and J&J’s Mentor division each control about half the market for breast implants, according to Nachman. Breast aesthetic devices accounted for 6.5 percent of Allergan’s $4.5 billion in revenue in 2009. The products are less significant to sales at New Brunswick, New Jersey-based J&J, the world’s largest maker of health-care products.
Allergan fell $1.36, or 1.9 percent, to $70.72 at 4 p.m. in New York Stock Exchange composite trading, the biggest single-day decline in a month. J&J slid 48 cents to $60.60.
Anaplastic large-cell lymphoma appears in different parts of the body including the lymph nodes and skin and affects about 1 in 500,000 women in the U.S. each year, the FDA said. The tumors are even less common in the breast with about 3 diagnoses annually per 100 million women.
Data reviewed by the FDA suggest women with breast implants may be more likely to develop tumors in the scar next to the implant as many as 23 years after their surgery. In some patients, treatment simply involved removing the implant and prognosis was better than in typical cases of the disease.
The agency hasn’t been able to identify whether the risk of cancer differs between silicone and saline implants or in cosmetic surgery versus reconstruction after a mastectomy.
‘Struck by Lightning’
“A woman is more likely to be struck by lightning than get this condition,” said Caroline Van Hove, a spokeswoman for Allergan, in an e-mail. “Patients’ safety is Allergan’s absolute first priority and we continue all efforts to collect and analyze further information about the very rare occurrence of ALCL in patients with breast implants.”
Regulators approved the use of silicone implants for cosmetic surgery in 2006, after 14 years of allowing them only for breast reconstruction because of concerns that women had been injured by leakage. The products have been on the market since before the FDA began regulating devices in 1976.
The FDA is working with manufacturers to revise their product labeling and plans to release an analysis of company-sponsored studies “later this spring,” William Maisel, chief scientist at the agency’s Center for Devices and Radiological Health, said today on a conference call.
“We fully support FDA’s efforts to gather additional data and study ALCL in patients with breast implants, said Christopher Allman, a spokesman for Mentor, in an e-mail.
The American Society of Plastic Surgeons will also work with the FDA to create a national registry to help track the risk of tumors in women with breast implants.
“For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science,” said Phillip Haeck, the physician group’s president, in a statement. “We are determined this shouldn’t happen again.”
“We don’t know what to think at this point,” said Marc Goodman, an analyst at UBS in New York, in a note to clients today. He said it’s possible the U.S. market for implants may shrink about 5 percent this year instead of expanding about 5 percent as he had anticipated. Goodman estimates Allergan’s U.S. sales of breast implants were $170 million in 2010 compared with $210 million for J&J.