Dow Corning Papers Show Fears of Implant ProblemsBy Malcolm Gladwell
The Washington Post
Dow Corning Corp. on Monday released internal memos, letters, and documents that revealed a history of worries that the company's silicone breast implants could rupture under certain circumstances and that the silicone could "bleed" through the outer shell of the prosthesis into the patient.
The company also announced Monday that it was replacing its chairman, John S. Ludington. He will be succeeded by Keith R. McKennon, formerly a vice president of Dow Chemical Co., which is a shareholder in Dow Corning.
"The McKennon appointment reflects the seriousness of the breast implant controversy," said Scott Seeburger, a spokesman for the company. "McKennon has broad executive management experience in public policy and government affairs. That background is very pertinent to a meaningful resolution of the mammary issue."
The company made the 800-page package, which included 27 scientific studies and numerous internal company documents spanning 25 years, available to the public Monday at the request of the Food and Drug Administration.
Among the contents was a 1987 letter that a Las Vegas plastic surgeon wrote to Dow Corning complaining that while removing an implant from a patient, the silicone inside it "literally ran to the floor" with the "consistency of 50 weight motor oil."
In an internal company memo, dated 1980, a salesman complained that Dow Corning's decision to put a "questionable" lot of saline-silicone "mammaries" on the market "has to rank right up there with the Pinto gas tank."
Dow Corning officials said Monday that the memos contained isolated complaints from a long and overwhelmingly favorable product history, and stressed that all of the scientific studies already had been reviewed by the FDA.
There also was no information in the package to confirm or deny allegations made by some physicians and product liability lawyers that leaky implants could cause autoimmune diseases.
"There isn't anything new here," said Robert LeVier, technical director of Dow Corning.
But the material contained in the more than 80 company documents in the package offer, for the first time, some clues as to why FDA Commissioner David A. Kessler ordered a moratorium on the use of all silicone implants last month, after reviewing the documents himself.
Public concern about the safety of breast implants increased in the past year as the FDA for the first time required manufacturers to provide evidence that their products were safe, and as a number of women successfully sued those manufacturers, arguing that the implants caused a variety of adverse health effects.
Both the FDA and the implant manufacturers agree that more research is needed into the question of what kinds of effect, if any, silicone implants have on human health. FDA officials believe implants pose little or no risk of cancer, but they want further investigation of a puzzling series of anecdotal reports of women with implants suffering from autoimmune disorders such as rheumatoid arthritis or the skin disease scleroderma.
Neither ailment is uncommon in middle-aged women, who make up a large part of the implant market. Federal health officials want to find out whether it is a coincidence that certain autoimmune diseases show up in those women. Dow Corning is now conducting a major epidemiological study of that question in Michigan.
Many of the questions raised by the documents released Monday, however, involve not autoimmune diseases but the quality of the product.
One issue is rupture. Implants consist of an outer shell filled with liquid silicone gel. When the shell is damaged, the gel can leak out. This happens most often during the operation to insert the implant, when the surgeon accidentally punctures it or squeezes it too tightly. It can also happen if the device is subject to some trauma after implantation.
Another concern is whether or not some amount of gel can "bleed" through the implant shell into the body.
FDA officials said that after reading the internal company documents in January, they became concerned that they did not have an adequate idea how often and under what circumstances rupture and bleeding occurred. Agency officials were also alarmed, they said, by the extent to which those concerns were shared by people within Dow Corning itself. For example:
* In a 1976 memo, Dow Corning engineer Tom Talcott wrote of his disappointment that at a symposium for plastic surgeons the company "ended up saying the envelopes were `good enough' while looking at gross thin spots and flaws in the form of significant bubbles. ... When will we learn at Dow Corning that making a product `just good enough' almost always leads to products that are `not quite good enough.' "
* In a 1978 memo, a company salesman in the Detroit area reported that four plastic surgeons were experiencing ruptures about 15 percent of the time while implanting what was then a new kind of silicone implant.