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New FDA-Approved Device Offers Promise Of Safer C-Sections

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LOS ANGELES (CBSLA.com) — A new FDA-registered medical device promising to eliminate fetal lacerations during Caesarean sections is gaining popularity.

Doctors are offering an alternative to the traditional scalpel, called the C SAFE, as C-sections approach a 33 percent national rate, increasing the risk of injury to newborns.

While the majority of fetal lacerations result in a small cut, extreme cases can include finger amputations and deep cuts leaving visible scars into adulthood.

“The traditional means of reaching the baby with a scalpel can sometimes go too deep and you can get a baby with a laceration,” Dr. Brigid McCue, OB-GYN, told CBS2. “The three percent that are deeper can be very severe,” she said.

Dr. McCue’s own daughter was nicked during a C-section, and she too lacerated a baby during delivery. The incidents made her question her own skill as a surgeon.

“It impacts the next 30, 50 Caesareans that you do. Everyone that you do is, ‘Ooohhh, are you sure?’ It’s devastating,” she said.

One local mother is thanking McCue for introducing her to the new technology.

Four years ago, Julie McGahan was stunned when her daughter was placed in her arms – her cheek sliced open by a scalpel as she was delivered by C-section.

“The surgeon came over to me right after the procedure and told me that unfortunately it nicked the baby’s face a little bit,” she said.

Mrs. McGahan said her daughter’s wound has healed nicely over the years, but she admitted the ordeal was distressing.

“It was upsetting because every time I looked at her face I would see the cut,” she said.

Fetal lacerations, like the one that happened to Sara McGahan, happen in up to three percent of traditionally performed C-sections.

Doctors using the C SAFE perform the initial incision using a blunt piece of plastic. The blade then faces up, never coming in contact with the baby.

When Mrs. McGahan’s OB-GYN told her she could undergo the procedure using the new medical device, the mother-of-three didn’t hesitate.

“She explained to me that she had this new device, that she’d love to use it and she asked me if I’d be interested and I said yes,” she said.

Dr. McCue delivered Mrs. McGahan’s third child last week using the C SAFE. The baby was perfect from head to toe.

Dr. Hector Chapa also works with C SAFE. He said it’s time doctors start opening up to the idea of performing the procedure differently.

“The ability to take home a healthy child should be every patient’s right. Taking home a baby that’s lacerated with stitches or bandages should not be the case,” he said.

For more information about the C SAFE, visit the company’s website.

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