Consumer groups in the U.S. are demanding that U.S. regulators postpone their final decision on Mentor Corp's silicone breast implants and are urging Congress to widen a related probe.
The National Organization for Women, Public Citizen and 13 other consumer groups, also threaten to take legal action if the U.S. Food and Drug Administration (FDA) refuses to release related documents.
The FDA said last month that Mentor could market its product once it met certain conditions; those conditions were not make public, and the groups are questioning the FDA's policy of approving devices then asking for more data.
They say they are concerned about a possible link between leaking silicone and certain diseases.
President of the National Organization for Women, Kim Gandy, says it is time for Congress to intervene and conduct a thorough investigation.
Surgeon groups and implant producers have said the newer silicone products are more durable and have low rupture rates.
Meanwhile a Senate health committee is already looking into allegations of conflicts of interest among members of an FDA panel that recommended approval of the implants in April.
In 2002 the FDA investigations into whether Mentor falsified records resulted in no charges being filed.
The consumer groups are now petitioning for all documents related to that investigation, and Mentor's current application, as well as the FDA letter about the conditional approval, to be released.
Public Citizen's Sidney Wolfe says, if that does not happen, they will seriously consider filing a lawsuit.
According to FDA spokeswoman Julie Zawisza, the agency cannot legally provide data on the company's new bid, but some documents from the earlier inquiry may be made available.
Mentor's president and chief executive officer, Josh Levine, dismissed the groups' concerns as "old news."
It appears that in a Securities and Exchanges Commission filing on Tuesday, Mentor said it was working to satisfy the FDA's conditions - it did not list what they were.
Mentor says it expects the FDA to recommend additional post-approval conditions or requirements.
Mentor's rival Inamed Corp. is also seeking U.S. approval for its silicone implants.