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Can a Stockert 3T Heater-Cooler Cause Surgical Complications?

When a patient undergoes lung or heart transplant surgery, it’s crucial that the operation occurs in a 100% sterile environment. Even a single trace of bacteria may cause a patient to develop a life-threatening infection. Transplant surgery patients are at an immunocompromised (weakened) state during surgery and they’re in an exposed condition for a long period of time. Surgeons and surgical assistants take every precaution necessary.

Everything from the equipment used to the members of the surgical team must remain sterile throughout an entire transplant surgery. This includes any devices that are responsible for providing oxygen to the patient, circulating water through equipment, or regulating a patient’s body temperature. Most devices are tested thoroughly by the manufacturers and are guaranteed to be sterile.

How Do I Know if My Hip Implant is Defective?

If you’ve had metal-on-metal hip replacement surgery, you’ve already been through a long surgery and recovery process that has almost assuredly affected your life and livelihood. As you’re recovering from surgery, you may have noticed certain side effects that are complicating the recovery process. Some side effects and complications are normal, but others are not.

You may also be aware that certain hip replacement implants are currently under FDA recall. Most hip implant surgeries have excellent outcomes, but others do not. Many of these poor outcomes are due to implants that are defective or do not hold up over time. When a hip replacement surgery patient is injured or suffers from a defective hip implant, that patient may face additional surgeries, a long and painful recovery process, or may not even recover at all.

Not All Types of Hernia Mesh Are Safe

When a patient suffers from a ventral hernia—a bulge of tissues, organs, or intestines that immerge from an opening in a patient’s abdominal wall—one of the safest ways to repair the hernia is by surgically inserting a bioabsorbable mesh patch over the opening in the abdominal wall. Bioabsorbable hernia patches are naturally absorbed by the body and allow the tissues to heal and become stronger over time, ensuring they’re held in place without complications.

Before 2010, most types and brands of hernia mesh patches on the market were created using components that the body could partially absorb. These patches were also made with porous materials that allow the tissues to naturally grow with the mesh itself. This prevents painful adhesions as well as reduces the chances of inflammation and infection.

In 2010, a company called Ethicon changed that with the creation of a new type of hernia mesh they called Physiomesh. Physiomesh was not required to be tested on humans since the manufacturer claimed the mesh was “similar” to other safe types of mesh. As a result, Physiomesh was rushed to market and widely used during surgeries nationwide.

EpiPen Recalls Defective Devices with Life-Threatening Malfunction

Four batches of the life-saving anti-allergy prescription medication EpiPen have been recalled.  The recall includes more than 80,000 devices that have already been distributed worldwide.  These defective auto-injectors possess the potential for either the failure to administer a complete dose of medication or the failure to activate at all.

EpiPen, a product of Mylan Pharmaceuticals, is a medication prescribed by a doctor to treat emergency cases of allergic reaction to food, medications, and insect stings and bites.  It is an injection device that automatically dispenses a premeasured dose of drugs containing epinephrine, a chemical that narrows blood vessels and opens airways in the lungs.  Epinephrine is used to reverse the dangerous symptoms of allergic reaction, such as severe low blood pressure, wheezing, severe skin itching, and hives.

What Products Get Approved by the FDA?

The U.S. Food and Drug Administration (FDA) is the government agency responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.  What may surprise you is that many of these products do not undergo an FDA approval process before they become available to consumers.  Some products are put through the approval process after they are already for sale.  But many of these common items are not nor will they ever be “FDA approved”.

The FDA does not approve companies.  Health care facilities, laboratories, and manufacturers are regulated by the FDA and the FDA has been given regulatory authority by Congress to act and investigate companies when safety issues arise.  Companies are required to comply with good manufacturing practices, but not required to undergo FDA approval.

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