Breast Implant Safety Data to Be Released
Dow Corning Wright, the leading manufacturer of silicone gel breast implants, will release 90 documents to the public related to the safety of the devices, including scientific studies and internal memorandums, company officials announced Wednesday.
Robert T. Rylee, vice president and chairman of health care businesses for the company, said Dow Corning Wright has agreed to a Food and Drug Administration request to make the materials public “to help alleviate the concerns that have been raised” since Jan. 6, when the FDA asked for a temporary halt in the sales and use of the devices.
Since then, the medical community--particularly plastic surgeons--and frightened women have been demanding access to the “new information” cited by FDA Commissioner David A. Kessler that led him to seek a temporary halt in the devices’ use.
The documents must be released by the company because the agency is legally prohibited from doing so. Rylee said the company hopes to make them available within 10 days.
About 2 million implants have been placed in women since they were introduced three decades ago.
In November, members of an FDA advisory panel concluded that scientific studies submitted by Dow Corning had failed to prove the safety of the implants.
Some established risks are associated with the devices, including hardening, caused by the scar tissue that develops around the implant after surgery, leakage of silicone gel, rupture of the device and interference with mammography.
But the most compelling unanswered question is whether the silicone in the implants causes cancer or autoimmune disease. Numerous women have attributed connective tissue disorders, such as arthritis and lupus, to the devices.
Rylee, speaking at a press conference, said the documents the FDA has asked the company to release include 10 scientific studies or reports and 80 pieces of internal company correspondence, much of it associated with litigation.
The company also called for the formation of a new scientific panel to examine the data before the agency makes a final decision on the fate of implants. “We believe that a panel should be made up of qualified experts from medical specialties such as immunology, rheumatology, toxicology and plastic surgery, where the true science can be examined,” Rylee said.
But a senior FDA official flatly rejected this idea.
Rylee said company officials are puzzled about why the FDA views the studies as new information. At least seven of the studies on the FDA request list have long been in FDA hands and were available to the advisory committee before it last met, he said. Rylee characterized the remaining studies as “old” or not relevant to implants.
FDA officials said, however, that some “were studies we had not seen before” that had “raised new concerns,” and that they had never been made available to members of the advisory panel.
Regarding the memos, many of which have already been reported widely in the media, Rylee said that releasing them will do “nothing to address the real science and safety issues.”
Nevertheless, he said, “we want to put to rest, once and for all, allegations . . . that we are in any way failing to make a full disclosure of all documents requested by the FDA.”
