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Norplant removals spur suits

THE BALTIMORE SUN

It took 20 minutes to insert six matchstick-size rods of %J Norplant into Mitzi Silber's left arm. But it took a whole summer to get them out.

The 34-year-old Westminster woman stopped using the contraceptive last year after her body began rejecting it. Removal took three trips to the doctor -- 45 minutes for the first two sticks, 90 minutes for the next three and 45 minutes for the last one, which had to be located by ultrasound exam.

Norplant's manufacturer, Wyeth-Ayerst Laboratories, had stated on its initial labeling that removal of all the sticks should be a routine, 20-minute procedure. However, the Philadelphia-based company did note in its product literature that 6.2 percent of users during clinical trials had removal difficulties.

The contraceptive, which consists of six capsules implanted under the skin of the upper arm, releases a hormone to provide up to five years of birth control.

Norplant came on the U.S. market in 1991 after being tested abroad for two decades. It is now used by nearly 1 million American women, and, whether they want new implants or not, all must have them removed when the devices run out.

Problems with removals have prompted two class action suits in the past five weeks. Ms. Silber and seven other Maryland women are joining a suit filed in Chicago.

Earlier this month, Wyeth-Ayerst submitted -- and the U.S. Food and Drug Administration approved -- changes in the labeling to address the removal problems and list possible side effects linked to Norplant that were not originally noted.

Locally, few problems have been reported by doctors at Planned Parenthood of Maryland, which administers Norplant at its seven clinics statewide, by practitioners at several local clinics and by the Baltimore health department, which oversees the administration of Norplant at family and school-based clinics.

At least eight Maryland women, including Ms. Silber, are among 600 plaintiffs in one class action suit filed against Wyeth-Ayerst, said Jewel Klein, the Chicago lawyer representing them.

She said the women are seeking damages of $20,000 to $50,000 each for medical costs and mental suffering caused by difficult removals, which many plaintiffs say resulted in heavy scarring.

They also want an injunction to prevent the company from selling the contraceptive to doctors who have not been trained to use it.

On July 15, 25 Florida women filed a class action suit in Miami, each seeking more than $50,000 from Wyeth-Ayerst for injuries they blamed on Norplant removals. The suit also contends the company failed to warn users of all possible side effects, said the women's lawyer, Ervin Gonzalez.

In changing its labeling, Wyeth-Ayerst deleted the clause at the crux of the lawsuits. Previously, the label stated that removal should take 15 to 20 minutes, but the revised version does not indicate how long it takes to insert or remove the contraceptive.

The updated label also lists additional possible adverse reactions, including emotional instability, heart attack, stroke, migraine, arm pain, numbness and tingling.

Birth control pills have some similar side effects, according to the FDA.

Audrey Ashby, a Wyeth-Ayerst spokeswoman, said the company applied for the label changes before the lawsuits were filed.

FDA spokeswoman Susan Cruzan said revising labels to reflect product users' experiences is standard procedure.

In a prepared statement, Dr. Marc W. Deitch, Wyeth-Ayerst's vice president and medical director, called the filing of lawsuits "inappropriate because Norplant removal is an individual procedure that is affected by a number of variables. These variables include how capsules were originally inserted, the procedure used for removal and circumstances that are unique to a given patient."

L For some local women, Norplant removals have been grueling.

Ms. Silber said her complications began soon after insertion, when the capsules migrated. "They felt like they were moving. I had lumps up and down my arm."

The last capsule, the one that had to be located by ultrasound, shifted to the edge of her armpit.

"I was furious about the whole thing. How safe can it be when they move up and down your arm?" Ms. Silber said.

Maya Huppert, 21, of Canton switched to Norplant last year, lured by its promise of convenience.

"[Norplant] was a breeze because they said, 'A 15-minute insertion, and it works within 24 hours,' and I said, ' Great,' " she recalled.

But she said she suffered unexpected side effects -- a 20-pound weight gain and a tender arm -- and had the six-capsule implant removed in January.

"It was pretty hard getting it taken out," said Ms. Huppert, who went to a Planned Parenthood clinic for all her Norplant procedures. "It took them about an hour and a half to remove -- two came out in shards."

The process, she said, required two new incisions rather than reopening the one used for insertion, as Wyeth-Ayerst recommends.

Ms. Huppert explained why she is joining the Chicago class action suit: "I could care less if I'm compensated or not because I'm over it. This makes people who put things on the market more responsible."

Wyeth-Ayerst says it has trained more than 28,000 U.S. doctors and practitioners in inserting and removing Norplant.

There is no requirement, however, for doctors to be trained in the procedure in order for them to administer the drug.

Planned Parenthood of Maryland clinicians have been trained to insert and remove Norplant, said spokeswoman Maris St. Cyr.

Patients are also told of Norplant's common possible side effects, which include irregular menstrual bleeding, headache, nausea, dizziness and nervousness. If women decide to receive the contraceptive after a consultation, they can only do so on a second visit.

Ms. St. Cyr says that since 1991, Planned Parenthood clinics statewide have performed about 1,200 insertions and about 200 removals, some for women who received the contraceptive elsewhere.

The city health department is satisfied with Norplant, health commissioner Dr. Peter Beilenson said.

"We have had no problems with our removals," he said.

Since 1991, city clinics have performed 198 insertions and 14 removals. In the department's school-based clinics, where Norplant was made available last year, there have been 45 insertions and no removals.

Dr. Beilenson said that city clinics do remove Norplant for those who had it implanted elsewhere.

Dr. George Huggins, chief of obstetrics and gynecology at Johns Hopkins Bayview Medical Center, believes problems with removals will diminish as medical providers become more experienced with Norplant techniques.

"As it turns out, the similarity between the model arm and the real arm for insertion is pretty good," he said. "Unfortunately, there is no perfect model for what happens during removal.

"In order to be good at removals, it takes people half a dozen times," Dr. Huggins said.

Since 1991, the Bayview clinic has made 2,000 insertions and 250 removals, with few difficulties, the clinic said.

The New York-based Population Council, the nonprofit group that developed Norplant and licensed it to Wyeth-Ayerst, stands by the contraceptive, which it says is one of the most effective, reversible methods of birth control.

"This is a method that many women like," said Sandra Waldman, a council spokeswoman. "I hope that [litigation] will not discourage people from using a very good method and encourage people to get the best training."

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