Silicone gel breast implant bill OK'd Legislation now goes to state Senate

March 21, 1992|By Marina Sarris | Marina Sarris,Annapolis Bureau

ANNAPOLIS -- A bill requiring Maryland doctors to comply with federal rules on silicone gel breast implants cleared the House of Delegates yesterday, in the wake of nationwide complaints that the implants may harm women's health.

The 123-5 vote came a day after Dow Corning Corp., a leading maker of such breast implants, announced it was leaving the implant business because bad publicity had made it unprofitable.

The Maryland bill, which now goes to the state Senate, requires physicians who insert breast implants containing silicone gel to follow the regulations and recommendations of the federal Food and Drug Administration.

An FDA advisory panel has suggested that the federal government make those implants widely available to cancer patients who want reconstructive surgery, but limit their use by healthy women who want larger breasts. Food and Drug Commissioner David Kessler is expected to issue a final ruling this spring.

The bill would allow the state to punish doctors who ignore FDA recommendations or rules on implants.

"The House vote struck a middle ground between banning [silicone gel implants] and not doing anything," said Del. Joan B. Pitkin, the Prince George's Democrat who introduced the bill.

Although the FDA regulates the implants themselves, it does not control a physician's practice, said Del. Virginia M. Thomas, a Howard County Democrat who serves as vice chairwoman of the Environmental Matters Committee.

The bill says violators could face disciplinary action from the State Board of Physician Quality Assurance, which has the power to test, license and revoke the licenses of doctors in Maryland.

The bill originally called for a temporary statewide ban on the implants. But the Environmental Matters Committee weakened the bill because members said such matters should be left to the FDA.

Delegate Pitkin vowed to call for a ban again next year if the FDA doesn't address the problem this year.

Sen. Paula C. Hollinger, a Baltimore County Democrat, predicted that the bill has a good chance in the Senate.

Questions about the implants' safety have centered around reports that they may pose a risk of "autoimmune" diseases and can rupture inside the body.

Some physicians have reported their patients have acquired debilitating diseases such as rheumatoid arthritis, lupus and scleroderma.

Others argue that rupture rates are very low and contend no evidence exists that autoimmune illnesses were caused by silicone spilling or bleeding from the implants.

The John Staige Davis Society of Maryland Plastic Surgeons supports the House bill as amended, said society president, Dr. Robert J. Spence in Baltimore.

"Physicians generally follow the rules and regulations of the FDA," Dr. Spence said.

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