In 2011, when the U.S. Food and Drug Administration first warned of a link between breast implants and a mysterious new cancer, it said the risk was vanishingly rare, far less than one in 500,000. Allergan, an implant maker, declared, "A woman is more likely to be struck by lightning than get this condition."
Now, seven years later, the scientific consensus is that implants with textured surfaces – not ones with smooth surfaces – cause the disease, called breast implant-associated anaplastic large-cell lymphoma. And although it certainly isn't common, it is far less rare than originally believed.
For women who choose certain types of highly textured implants, the risk after a decade of wearing the devices could be as great as 1 in 2,200, estimates Mark Clemens, a plastic surgeon at MD Anderson Cancer Center in Texas, which has become a leader in treatment and research of implant lymphoma.
"We're still trying to understand if there is a differential risk with the type of texturing and length of exposure," he said.
Given the debatable advantages of roughened surfaces and its undeniable link to the lymphoma, a small but vocal group of plastic surgeons says such devices should be abandoned, if not yanked from the market.
"No one can prove any benefits to texturing," declared David A. Hidalgo, a prominent New York City plastic surgeon and professor at Weill Cornell Medical College. "If you remove the products, the risk goes to zero. To me, it's a no-brainer. Personally, I think they shouldn't be on the market."
Eric Swanson, a plastic surgeon in suburban Kansas City, Kan., agrees. "Even a remote risk is ethically indefensible if that risk is entirely unnecessary," he wrote recently in JAMA Oncology.
Asked to respond, the FDA and the three companies with FDA-approved implants — Allergan, Mentor, and Sientra — said in statements that they are supporting implant lymphoma research, education, and initiatives to better understand the disease and increase awareness.
"But for now," Sientra added, "we are concerned that suggesting only smooth implants should be used is not based on good science and creates unnecessary alarm for a rare and usually treatable disease."
Since the first report of implant lymphoma in 1997, there have been 570 cases and 16 deaths reported worldwide, including 230 cases and five deaths in the United States, according to a July 30 update from the American Society of Plastic Surgeons.
The first symptom of the lymphoma – an immune cell malignancy that is distinct from breast cancer – is usually swelling around the implant. It typically appears after about nine years of wearing textured devices, no matter whether they are filled with saline or silicone gel.
If promptly and properly treated by removing the implants and the surrounding capsule of scar tissue, the cancer can usually be cured. However, because health insurance doesn't cover cosmetic implants or complications, some women have delayed seeing a doctor or had trouble getting coverage of treatment. And the disease still isn't on the radar of many physicians.
"Women are desperate for increased clinician awareness in radiology, pathology, emergency medicine, ob-gyn, and general practice," said Terri McGregor, 53, of North Bay, Ontario.
McGregor co-founded a Facebook page devoted to helping affected women after she almost died of metastatic implant lymphoma. It caused no symptoms before it was accidentally discovered following her first screening mammogram in 2015.
Many mysteries still surround the illness, including how and why it develops. Experts believe chronic inflammation is a culprit. But genetic factors must play a role because some Asian and South American countries where textured implants are used almost exclusively have reported few or no cases.
In the U.S., textured products — which cost more than smooth versions — make up only 12 percent of the market. Last year, there were 300,000 breast enlargements and 87,000 reconstructions after mastectomy, according to the American Society of Plastic Surgeons.
Clemens' estimate that the lymphoma risk could be as high as one in 2,200 after a decade is extrapolated from two studies of Allergan's Natrelle 410 textured implants. Out of 17,656 women, eight have developed the cancer to date – a rate of about one in 2,200.
Swanson, in Kansas, and Donald R. Mackay, a plastic surgeon at Penn State Hershey College of Medicine, have argued in the Aesthetic Surgery Journal that ethics, not statistics, are paramount: The statistics "do not consider the pain, suffering, and the emotional and financial impact to affected patients and their families."
Introduced in the early 1990s, texturing involves using chemicals to etch the surface of the silicone pouch. The roughness helps anchor the device in place as tissue grows into the tiny crevices – but it may also trigger chronic inflammation.
Texturing was touted as a way to reduce breast hardening, called capsular contracture, a major reason for reoperation. Texturing was also supposed to prevent the rotation of teardrop-shaped "anatomical" implants, which some surgeons and women consider cosmetically superior to round implants.
Many plastic surgeons who have stopped using textured products are unwilling to dictate what their colleagues should do. Clemens, for example, helped write an American Society of Plastic Surgeons' document that says, "The plastic surgeon must provide a frank and transparent discussion of the benefits and risks of implants, both smooth and textured."
But Clemens no longer offers textured because, he said, "In my practice, there are no benefits."
Hidalgo said that when implants are placed under the chest muscle wall, as is standard, "there is no good evidence that textured implants prevent capsular contracture." Studies also show some teardrop implants rotate into wrong positions despite texturing.
As for the cosmetic superiority of anatomical shapes, Hidalgo believes it's a matter of opinion, and "a lot of surgeons are influenced by their (financial) connections to the industry."
Hidalgo even tested the superiority premise with a controlled study: 75 women agreed to get mismatched implants – one round, one teardrop – during surgery so photos could be taken. Then the teardrop implants were replaced by round ones and the surgeries were completed.
Plastic surgeons and lay people who evaluated the photos either saw no difference between the teardrop and round implants, or else they preferred the round implant just as often as the teardrop shape.
In the last few years, law firms in Philadelphia and across the country have filed suits on behalf of women who developed implant lymphoma. No cases have been decided yet, but Hidalgo says he believes "the handwriting is on the wall."
"Although industry, our specialty, and the U.S. Food and Drug Administration are slow to proactively condemn textured devices, the legal system is not," he wrote in the journal of the American Society of Plastic Surgeons.