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Protocols in place at UIHC after Allergan breast implant recall

IOWA CITY, Iowa (KWWL) — Following the recent Food and Drug Administration.recall of Allergan textured breast implants, previously used at the University of Iowa Hospital and Clinics, the hospital has announced it is contacting patients with more information.

The University of Iowa Hospitals and Clinics will be reaching out to all past patients who received the Allergan breast implants. Hospital officials will notify patients about what type of implant they have and protocols UIHC is putting in place.

This comes after the F.D.A. recommended a recall of Allergan Textured Implants, two weeks ago. The implants have been linked to a rare type of cancer, called anaplastic large cell lymphoma (BIA-ALCL).

The notification letters were sent out Monday, August 5, contacting patients as far back as 2006, regardless of the type of implant they’ve received.

UIHC Professor and Chief of Plastic Surgery,Dr. Thomas Lawrence, said this is an effort to make sure patients are aware, and can keep an eye out for possible symptoms. Although the disease is considered rare by the F.D.A., with 573 cases of BIA-ALCL reported worldwide.

“The evidence was to a point, I think where none of us were using them anymore and so it doesn’t really surprise me that they’d be taken off the market,” said Dr. Lawrence.

He says the hospital hasn’t used Allergan textured implants for at least the last six months.

“Whereas previously we thought the incident was 1 in 100,000s. More recently, info suggested the true incident is 1 in 3,500 and 1 in 30,000,” said Dr. Lawrence.

Since news of the recall, he says women have reached out to get an idea about their risk. An Iowa City woman, Tara Armstrong even getting her’s removed after attending an F.D.A. meeting earlier this year. She’s become a patient advocate.

UIHC is following suit, observing not just the new FDA guidelines, but also putting in place their own protocols.

“The FDA has not recommended that individuals who have textured implants have them taken them out prophylactically, if they’re not having any problems,” said Lawrence.

He says the F.D.A. has determined the risk of surgery could be greater than the chance of the disease, calling it low risk in a news release. 

However, UIHC has put a protocol in place for patients who may be showing symptoms such as swelling or fluid collection.

“In terms of having it evaluated with an ultrasound test and then having fluid if it’s identified, aspirated and sending it away for specific tests,” said Lawrence.

According to the UIHC, over 95% of patients with BIA-ALCL who present with local symptoms do so an average of approximately nine years after implant placement.

For more information regarding the protocols or BIA-ALCL, visit the UIHC website. 

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Ashley Neighbor

Reporter, Cedar Rapids

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