FDA Initiative to Improve Safety of Infusion Pumps Not Recall for Plastic Surgeries in Time for Swimsuit Season

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Goal of initiative to minimize risks--pain pumps remain safe, effective way to control postoperative pain, according to local surgeon. Dr. Leo Lapuerta states the pain pumps are beneficial and are great for patients looking to get a surgery done in time for summer.

a balanced public health approach

In April 2010, the FDA recently began an Infusion Pump Improvement Initiative to address some safety issues related to many models of pain pumps, but this should not be confused with a recall or ban. Dr. Leo Lapuerta of the Plastic Surgery Institute of Southeast Texas says it's important for patients to understand the benefits of infusion pumps; especially this time of year when cosmetic surgeries go up for the swimsuit season.

An infusion pump is a device for delivering a controlled, consistent dose of medicine. They are commonly used to deliver local anesthesia to a surgical site to control discomfort during the immediate recovery period. When used for this purpose, they are often referred to as "pain pumps."

The FDA action is not a recall or ban of infusion pumps, but an attempt to make pain pumps even safer. According to the FDA white paper it is part of "a balanced public health approach" in which "FDA seeks to support the benefits of infusion pumps while minimizing the risks." As part of the initiative, the FDA seeks to:

  •     Establish additional requirements for infusion pump manufacturers
  •     Proactively facilitate device improvements
  •     Increase user awareness

With the ultimate goal of "[supporting] the safe use of these vital medical devices."

According to Dr. Lapuerta, the "take home message" of the FDA action is that patients should pay close attention to postoperative instructions. "Problems with a pain pump are rare, but we will tell you what to do in the event that your pain pump does experience a problem during use."

"We commonly use a pain pump after tummy tuck procedures," adds Dr. Lapuerta. "A tummy tuck is major surgery and can result in significant discomfort during recovery. In my opinion, a pain pump is better--and safer--than using narcotics to control discomfort after surgery."

According to Dr. Lapuerta, the benefits of using a pain pump include:

  •     Patients can go home the same day of surgery
  •     Pump makes recovery more comfortable
  •     Provides better pain relief than narcotics
  •     Results in less nausea than narcotics
  •     Works continuously for 72 hours
  •     Numbs surgical area without affecting entire system like oral narcotics
  •     Better recovery for people who need to be at least minimally active during recovery

He also notes that the Plastic Surgery Institute of Southeast Texas follows FDA and manufacturer guidelines for the safe use of pain pumps.

About Plastic Surgery Institute of Southeast Texas

The Plastic Surgery Institute of Southeast Texas is the private practice of triple-board-certified plastic surgeon Dr. Leo Lapuerta. It offers a wide variety of plastic surgery procedures such as breast enhancement, body contouring, and facial plastic surgery. Dr. Lapuerta serves patients in the Houston area at three locations: 1919 LaBranch, 11800 Astoria Boulevard, and 2360 County Road 94 in Pearland. Dr. Lapuerta is board certified in general surgery, plastic surgery, and surgery of the hand. He has hospital privileges at several area hospitals. Dr. Lapuerta is also the director of the Clinical Skin Care Center.

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Ashley Martin
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