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Bioplasty Withdraws Applications For Approval of Breast Implants

March 5, 1992

ROSEVILLE, Minn. (AP) _ A producer of silicone gel-filled breast implants said Thursday it has withdrawn an application to market the devices.

The move by Bioplasty Inc. means the company’s Misti Single and Double Lumen implants will no longer be commercially available in the United States. The implants also will no longer be exported from this country, said Timothy Lawin, Bioplasty president and chief executive officer.

Lawin said Bioplasty decided to withdraw an application before the Food and Drug Adminsitation to market the implants after an FDA advisory panel recommended last month to restrict use of the silicone gel implants.

The FDA maintains there is too little evidence that silicone gel breast implants are dangerous to ban them outright. But in January, FDA Commissioner David Kessler called for a moratorium on sales after reports showed some implants can rupture within women’s bodies, causing serious health problems.

Last month, the FDA advisory panel recommended the implants should be limited to women recovering from breast cancer or others needing full breast reconstructions.

Bioplasty filed applications to market the implants last July.

Bioplasty and three other implant makers had been criticized for continuing to sell the implants abroad despite the FDA’s request for a worldwide halt to such sales, the Wall Street Journal reported in Wednesday’s editions.

Bioplasty, Mentor Corp. of Santa Barbara, and Inamed Corp. of Carpinteria, near Santa Barbara, have complied with the FDA’s voluntary ban on selling the implants in the United States, the Journal said.

Only Dow Corning Corp., the largest of the manufacturers and the one on which the implant controversy has focused, has also halted foreign sales, the Journal reported.

The companies did not dispute that they continued to sell silicone implants overseas.

Groups seeking to outlaw the implants were outraged. FDA spokeswoman Susan Cruzan said foreign sales were clearly against the wishes of the FDA, as revealed in a Jan. 16 letter the agency sent to Bioplasty.

″Our request for a moratorium on the manufacture and distribution of silicone gel filled breast implants applies to both domestic and foreign distribution of domestically produced product,″ said the letter.