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SHRUM PATIENT CONCERNED ABOUT SAFETY, EFFECTIVENESS OF UNAPPROVED IUD

By Amy Riggin/OF THE COMMERCIAL STAFF
Saturday, June 27, 2009 10:46 PM CDT

A local woman is unsure what to do now that federal officials have notified her that the intrauterine device she has, which was implanted by Pine Bluff Dr. Kelly Shrum, could be unsafe or ineffective.

The 25-year-old, who wished to remain anonymous, received the implant in October at Shrum’s recommendation after giving birth to her second child.

She was notified by the Food and Drug Administration this week after federal investigators found devices in Shrum’s office, the Arkansas Center for Women at 1609 W. 40th Ave. The devices were manufactured in Europe and are not FDA-approved. Another version of the same device, Mirena, is approved and manufactured in the U.S. by Bayer HealthCare Pharmaceuticals.

The investigation is ongoing and federal and state officials have declined further comment.

After reading the letter mailed to her, the woman said Friday that she still has a lot of questions and concerns.

“I thought maybe it would say something about what we’re supposed to do,” she said. “I’m going to make some phone calls to see if I need to get this thing taken out and who I need to go to.”

The U.S. Attorney’s office, in making the announcement Tuesday, advised patients to consult their primary care physician, the Jefferson County Health Unit at 535-2142 or the FDA at 913-384-7429.

The woman said she had used Depo-Provera, a form of birth control administered as a shot in the arm, before Shrum suggested Mirena. “I had bleeding for a long time and cramps — really bad cramps — and I still get really bad cramps,” she said. “And I don’t know if that’s what it’s from but it happened since I’ve had [Mirena].”

The woman said Shrum asked her what form of birth control she wanted before suggesting Mirena.

“I told him I would prefer the Depo shot and he’s like, ‘No, you’re not getting the Depo shot. You’re going to get the Mirena because it doesn’t have any side effects; it doesn’t have the weight gain and irritability,’” she said. “Since he was my doctor I took his word and said, ‘OK, let’s do it.’”

Now that the news of his investigation has spread, her concerns are growing.

“At first I couldn’t believe what was going on,” she said. “Now I’m just concerned as to what’s going to happen. Do we need to get it taken out? Are there side effects from it? Is it going to affect me later on?”

She said she “never had problems with the shot.”

“I’ve had more problems with this than I have anything,” she said.

She said Mirena, for her, has been effective in preventing pregnancy but she likely will go back to getting the shot.

Tyrone Tidwell, administrator at the Jefferson County Health Unit, said some of Shrum’s patients had contacted the facility.

“They’ve just been calling to see if they could be seen,” he said. Others have come in person. “I haven’t personally seen anybody that’s been in a panic or anything like that,” Tidwell said.

Patients have asked questions about what they need to do, which are answered by nurses on staff and are case dependent.

“One of the first questions [nurses] ask is when they had the IUD put in,” he said. “A lot of it depends on when they had it done.”

According to the FDA Office of Criminal Investigation hotline set up to provide information for Shrum’s patients, only patients who received IUDs in 2008 and 2009 could have received the unapproved devices. “If they want to come here we’ll get them in to have it removed and have a new one put in” or provide alternate means of birth control, Tidwell said.

Also Friday, Jefferson Regional Medical Center issued a statement in response to the investigation confirming that Shrum has privileges at the hospital and is a tenant at the Jefferson Professional Center, which is owned by the Jefferson Hospital Association. But Shrum is not a hospital employee and the hospital “is not involved in Dr. Shrum’s practice.”

Spokeswoman Lisa Rowland declined to elaborate on what privileges Shrum had or whether they would be revoked.

“JRMC had no knowledge of the incident involving Dr. Shrum until after it had taken place,” said President and CEO Bob Atkinson. “We were never notified by authorities that the visit was taking place and because Dr. Shrum is an independent practitioner, we have no reason to believe that JRMC plays any role in this investigation. It is a private matter for the physician involved, and as a result, JRMC will have no further comment.”

A woman who answered the telephone at Shrum’s office Friday morning said Shrum was “in an exam room” and referred questions to Little Rock attorney Jack Lassiter. Lassiter could not be reached for comment Friday.

Shrum’s office was searched on June 17 and Jane W. Duke, U.S. Attorney for the Eastern District of Arkansas, issued a statement Tuesday.

On June 19 the Arkansas Department of Human Services notified Shrum that Medicaid payments would be suspended because of “reliable evidence indicating you are involved in circumstances involving fraud or willful misrepresentation...”

DHS referred the matter to the Attorney General’s office; a spokesman declined comment Friday.

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