Pellet hormone replacement therapy has been available and researched for more than 70 years. Since the early 1940s, reports have appeared in a wide range of respected international journals supporting the many benefits of this method. In fact, bioidentical pellet HRT, when properly administered, is scientifically recognized as the safest and most effective hormone replacement method available.
But not all bioidentical pellets or pellet implant methods are the same. We often see patients who have switched to SottoPelle® from other providers because they heard about our special procedure and the effectiveness of SottoPelle® therapy. Time and again they tell us how much better they feel on our pellets as opposed to their previous experience with the pellet implant method.
The Difference Between Other Pellets and Those Used by SottoPelle®
There are at least a couple of good reasons why other pellets don’t work as well. First, many manufacturers use synthetic fillers and binders in their process. These can interfere with the absorption rate and effectiveness of the HRT. Another problem can lie in the manufacturing method used to fuse the hormones into pellet form. This process has a direct relationship to how long the pellet will last and how much hormone gets released. Pellets can either dissolve too quickly or not dissolve properly, prohibiting the consistent, slow release of low doses of hormone needed for hormonal balance.
SottoPelle® is proud to say that the pellets we use are 99.9% pure hormone (bioidentical estradiol or testosterone) plus a human fatty acid (0.1%) to bind them together.
Our Pellet Manufacturer is FDA Regulated and Unsurpassed in Quality
We use one of the finest manufacturing facilities in the industry to make pellets for us. As an FDA-regulated 503B manufacturing site,* it is held to the very highest standards currently set by the FDA. The facility features a state-of-the-art manufacturing environment with advanced equipment, training procedures and testing, in addition to an expert team of well-trained, licensed pharmacists and certified pharmacy technicians.
To manufacture hormone pellets, they start with the highest quality, FDA-regulated ingredients available. Using current good manufacturing practices (CGMP) the bioidentical hormones are fused into tiny cylinders. Samples are then sent to independent laboratories for testing. This ensures that the pellets have the proper density, potency, purity, sterility, solubility, rate of disintegration, and temperature tolerance. In fact, the pellets they manufacture consistently meet or exceed industry and regulatory standards for quality and safety.
Their very meticulous manufacturing process combined with our own precision BHRT method are what make SottoPelle® Therapy the reliably effective hormone replacement method it is.
*What is a 503B Manufacturing Site (Outsourcing Facility)?
In November of 2013, President Obama signed into law the Drug Quality and Security Act which sets forth new, more rigorous standards for the pharmacy industry. The bill contained a section known as the Compounding Quality Act. Under the 503B section of this new law, outsourcing facilities must comply with current good manufacturing practices (CGMP), register with the FDA, and comply with reporting and inspection requirements.
Be sure to ask your doctor if their pellets are made in a FDA certified 503B facility. If not, you have to question their quality, effectiveness and safety.