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Thu July 15, 2010
Use of un-approved birth control devices common in U.S.
By Megan Hall
Providence, R.I. – More than 60 women have joined a class-action suit after it was discovered that 10 Rhode Island practices implanted un-approved IUDs in them. The doctors allegedly obtained the cut-rate birth control devices on line from Canada.
Carmen Pecoraro of Providence was among the first plaintiffs in the class action lawsuit. She says she was astonished when she discovered her physician was one of the doctors that used IUDs that were not approved by the Food and Drug Administration, or FDA.
"I really trusted my doctors and I feel like I've been mislead and lied to," said Pecoraro. "And if they're not telling you the truth about things, who is?"
Pecoraro received her IUD from OB-GYN Associates, a practice with offices in Rhode Island and Massachusetts. OB-GYN Associates has sent letters to many of its patients, informing them that they received un-approved IUDs. Pecoraro has not received a letter yet, but hundreds of her fellow patients have. And now more Rhode Island doctors are admitting that they, too, implanted the un-approved devices.
The reason? Price.
It turns out doctors can buy IUDs over the internet for about half the cost of those approved by the FDA.
"They just thought, wow, this is a great deal," said lawyer Tracy Green. " Don't be a knucklehead and over pay."
Green practices in Los Angeles, and she represented five doctors who did the same thing three years ago in California. She says the practice was pretty widespread.
"One of my doctors, it was another OBGYN who called him and said, Boy, my office, we found a great price.' And you know, they're all board certified OB-GYNs," Green said. "They just thought this was a great deal."
Green says the IUDs appeared to be identical to the ones the doctors usually prescribed. They even had the same packaging. The lawyer representing the Rhode Island doctors who bought the UN-approved IUDs declined to speak on tape for this story, but he's argued the same thing: There was nothing different about these devices; they were just cheaper because they came from Canada.
"If it's not FDA approved, it's not the exact same product, otherwise it would be FDA approved," said David Gifford, director of the Rhode Island Department of Health. "What the differences are, we don't know."
He says the FDA is still trying to determine whether the IUDs were approved for use in Canada or whether they were cheap knock offs. But Gifford says the more important issue is that doctors betrayed their patient's trust.
"If you elect to go up to Canada, and buy something, you know you're doing that," Gifford said. "That's the risk you're taking. Here, I don't think women were given that choice."
The practice of using non-approved IUDs isn't limited to doctors in California and Rhode Island. In 2009, an Arkansas physician was indicted for the same thing. And last year, The Journal of Family Practice warned doctors about the risks of buying IUDs off the internet.
MIT professor Jonathan Byrnes is an expert on how medical devices are supplied and distributed. He says the use of non-approved IUDs is just one piece of a larger trend of doctors buying products from other countries.
"Well, it's reasonably widespread, it's especially noticeable in pharmaceuticals where there's a big price difference," he said.
Byrnes says in some cases the products really are similar - even identical - to those approved for use in the U.S. But they're often cheaper in countries with government-enforced price controls.
"I think that anybody who has followed the recent health care legislation discussion would understand that the pharmaceutical companies wield a lot of power and want to keep prices high," Byrnes said.
Brynes says the risk of using these products comes not from the factory, but from the supply chain. When doctors buy devices from approved channels, they can guarantee they're safe. But nobody can really vouch for an IUD bought from a random web site. Brynes says in some cases the devices might not even come from Canada.
"There is pretty serious risk in both cases, where a person is dealing with potentially serious consequences," said Byrnes. "It's a risk that I wouldn't want a family member to take."
But with such a big difference in price, some doctors are tempted to overlook the risk of buying them across the border. Pablo Rodriguez is a gynecologist and the former medical director of Rhode Island's Planned Parenthood. His practice didn't use the non approved IUDs, but he says many others probably did.
"I think this is probably a widespread issue because health care in this country is extremely expensive and providers in this country are finding problems constantly trying to get reimbursements from insurance companies," said Rodriguez. "I wouldn't be surprised if this appears in other states."
Rodriguez says he pays $700 for every IUD, and he's not reimbursed until after they're implanted. That means his practice has to pay a lot of money upfront.
"You know, we put hundreds of these a year, so you can imagine hundreds of IUDs at $700 a pop, it does make for a very expensive on the shelf item," he said.
Rodriguez says doctors will be tempted to buy cheaper medical supplies from other countries for as long as the U.S. fails to control medical costs. But with a class action suit under way, doctors in Rhode Island might be a bit more cautious going forward.