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Norplant faces US lawsuits

in Bermuda are facing increasing numbers of lawsuits in the United States, a newspaper has reported.

The New York Times reported last Sunday that Norplant, which is implanted just under the skin of women, "is the target of an avalanche of lawsuits brought by many of the same lawyers who went after the makers of silicone breast implants''.

Manufacturers of silicone breast implants earlier this year agreed to a $4.2 billion settlement of claims by women who used the implants.

But local Government officials have dismissed concerns about the device, saying it has been determined to be safe according to the scientific literature and the Food and Drug Administration.

Doctor-in-charge at the Maternal Health and Family Planning Clinic in Bermuda Dr. Cheryl Peek-Ball said she did not have a whole lot of fear with the terms of the lawsuits against Norplant in the US.

"It is the scientific literature that we use to determine what products are safe and effective to use, and it must have Food and Drug Administration approval,'' Dr. Peek-Ball said.

She added that only after years of use of a product "do we become fully aware of the range of side effects and long term risks of using the product''.

But Dr. Peek-Ball also said that she was not aware that the device, which gives contraceptive protection for five years, was silicone-coated.

Health and Social Services Minister the Hon. Quinton Edness said he had no information on the implant and referred The Royal Gazette to his officials.

Though he would have had to approve the medical device, only Ministry officials could respond to questions about technical details, Mr. Edness said.

The New York Times said the product consists of "six tiny silicone-coated rods, which are inserted under the skin of the patient, is the target of an avalanche of lawsuits brought by many of the same lawyers who went after the makers of silicone breast implants''.

"And working with these lawyers are many of the same medical experts and laboratories that made money diagnosing silicone-related diseases in women with breast implants.'' Wyeth-Ayerst Laboratories, the division of the American Home Products Corporation that sells Norplant, says it has no plans to pull the device off the market because of the attacks on its silicone content. But it says that the adverse publicity and negative word-of-mouth have driven sales down from a robust 800 a day to about 60.

It also stated that while the Food and Drug Administration -- the Government agency responsible for protecting public health -- has approved Norplant, and while numerous controlled studies have found it safe, "the lawsuits against the device assert a wide array of side effects such as memory loss, muscle pain, depression, autoimmune disorders, infections, seizures, blindness, cancer, and heart attacks symptoms of silicone disease''.

But Dr. Peet-Ball added that the levonorgestrel hormone, which is a type of progesterone that is in Norplant and many birth control pills, has been used for decades and "it would be surprising to find side effects that have not already been documented''.

"Norplant is nothing new, it is just that the means of delivery is new, with the insertion of the device in the arm.'' Dr. Peek-Ball also said that she would feel safe recommending Norplant, and "it is very unlikely that there are going to be a lot of surprises. The product has no reason to be unsafe.''