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US lawmakers question FDA breast implant decision
By Lisa Richwine
WASHINGTON, May 11 (Reuters) - Members of Congress on Thursday questioned U.S. health officials' decision to allow saline-filled breast implants to remain on the market after studies found they carried risks of health complications.
The Food and Drug Administration announced late Wednesday that it would permit the two leading implant makers to keep selling the products but stressed that women should be warned about risks, including the possible need for repeat surgeries.
Studies by the companies, Inamed Inc.'s (NasdaqNM:IMDC - news) McGhan Medical unit and Mentor Corp (NasdaqNM:MNTR - news), found more than 20 percent of women with implants required surgery to remove or replace them. Other complications included breast pain, leakage or deflation and hardening of tissue surrounding the implants.
``Why would the FDA allow such devices into the marketplace when they are likely to cause pain, hardship, distress and added expense for thousands of women?'' asked Representative Roy Blunt, a Republican from Missouri.
Blunt has asked the House Commerce Committee to hold hearings on the FDA decision, his spokesman said. Other members said they were appealing to the FDA for more information.
``The FDA itself has recognised that there were concerns about these implants, and we hope to monitor the situation with the FDA,'' said Representative Ron Klink, a Democrat from Pennsylvania.
House Commerce Committee Chairman Thomas Bliley, a Virginia Republican, wants to know why the FDA is allowing Mentor to continue selling its implants despite an ongoing criminal investigation, a committee spokesman said. Committee staff members have asked the FDA to provide a private briefing on the matter next week, the spokesman said.
``We are concerned about the fact FDA moved forward on this,'' the spokesman said. ``We will continue to press them to give some sort of rationale to Congress and the American people.''
In announcing their decision, FDA officials acknowledged the implants' risks but also noted that the majority of women who still had implants after three years were happy with them.
``With the data that has been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks,'' FDA Commissioner Jane Henney said in a statement.
Implants filled with saline, or salt water, have been sold in the United States for more than two decades. Because they hit the market before the FDA had authority over medical devices, they were never officially approved.
The FDA agreed to scrutinise saline implants after questions arose about the safety of silicone-gel implants, which the agency banned for most women in 1992. |
