News

UNAPPROVED IUD DEVICES FOUND AT PINE BLUFF DOCTOR’S OFFICE

By Ray King/OF THE COMMERCIAL STAFF
Wednesday, June 24, 2009 11:44 AM CDT

Federal authorities are continuing their investigation into unapproved intrauterine devices that were found last week in a Pine Bluff doctor’s office.

U.S. Attorney Jane W. Duke said a version of the device Mirena that has not been approved for use in the United States was found when agents from the Food and Drug Administration Office of Criminal Investigations served a search warrant at the office of Dr. Kelly Shrum at Arkansas Center for Women, 1609 W. 40th Ave., June 17.

An IUD is a device used to prevent pregnancy.

“The United States Attorney’s Office has reason to believe that some of Dr. Shrum’s patients received a version of that product that was manufactured in Europe for distribution outside the United States,” Duke said in a news release. “It is unknown whether that version is safe and/or effective.”

Safety findings

Duke said generally, only those products that have received FDA approval may be brought into the United States legally, and they have not made any findings regarding the safety or efficiency of the versions of the device that have not gone through the FDA approval process.

She said patients who may have received the foreign version of the IUD are being contacted by mail, and those who do not receive a letter can call the FDA at (913)-384-7429.

Patients who have medical questions should contact their primary care physician, or the Jefferson County Health Unit at 535-2142, Duke said. A representative of the FDA can also be contacted at (913) 384-7429.

Duke said that because the investigation is ongoing, no additional details will be released at this time.

Shrum could not be reached for comment Tuesday.

Print this story   |   Email this story