Viewpoints

A few readers have asked about the cost of testicular prostheses. As with many other devices and surgical procedures, testicular implants must be purchased by a hospital or physician prior to the procedure.

Also, implants are typically covered by health insurance policies, but given the varied nature of carriers and plans we recommend speaking directly with your insurance contact about how the procedure will be covered.

For product details and other information about implants, please refer to the Product Information pages.

Photo credit: Photos8.com on flickr

If you’ve browsed through the contents of this website, you may be wondering what you should do next. Aside from reading our material and visiting other recommended websites, we invite you to take a brief survey about your experience with the site. Also, if you have a specific question regarding Coloplast products, please contact us using the online contact form. If you’d like to contact a urologist in your area, please use the online physician finder on our Straight Talk website.

Prior to speaking with your physician or urologist, we recommend writing down a few questions to guide the conversation, and help you understand your doctor’s perspective on testicular implants and the procedure. Here are a few to get you started:

• Would you recommend testicular implants for me?
• What is your experience with implants?
• How would you describe the procedure?
• How have your patients described the recovery?
• What are the risks and possible complications?
• What advice would you give someone who is considering this procedure?

Lastly, be sure to consult with your insurance company to confirm that they will cover the procedure. Most policies will cover testicular implants, but make sure you understand how this will work through your insurance plan.

How do clinical trials guarantee the safety of a medical device? According to US regulatory policies, every medical device must pass rigourous testing in order to gain FDA approval. Coloplast testicular implants are the only prosthetic testicles on the market to have FDA approval, so it is important to understand what this means. Last year we published a post describing how FDA approval works, but we didn’t provide much detail about clinical trials. After reviewing a few sources, we think this page from the US National Institutes of Health sums up the purpose and structure of clinical studies nicely:

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Click here for detailed information about the clinical trials for Coloplast’s Saline Filled Testicular Prostheses.

Click here to download the PDF version of the FDA approval order for Coloplast testicular implants (please note that at the time of approval, our product was filed under “Mentor Saline-Filled Testicular Prosthesis.”

High traffic medical information websites like WebMD or MayoClinic.com are good places to read about nearly any medical condition or treatment, but many academic hospitals maintain excellent resource information online. For information related testicular implants, we recommend reviewing information from two of the country’s best urology institutes:

Columbia University Medical Center, Center for Holistic Urology
Contains authoritative information about numerous topics in urology, such as treatment for testicular cancer and the use of testicular implants.

Johns Hopkins Hospital Urological Institute
Offers a breadth of information about testicular health, including the use of testicular implants in children.

While this website has been primarily designed for patients, we have compiled some information for physicians. Most of this content is located on Straight Talk, our other men’s health site, where doctors also can access information about other Coloplast products, such as penile implants.

Physician highlights on Straight Talk include:

• Downloadable .pdf brochure about testicular implants
• Overview of product features
• Product safety details
• Patient satisfaction details
• Instructional Filling Video

Physicians may also want to visit the Patient Information part of this website, which includes a full range of information about the procedure, recovery, possible reactions, and other details.

Yes, in many cases it is appropriate for a child to receive testicular prostheses. However, as with any medical decision, all patients (and their parents) should speak with a physician and learn as much as possible about their condition and treatment options. The use of implants in children is often the result of the loss of a testicle due to injury or testicular torsion. Implants may be recommended for children with undescended testicles that must be removed for medical reasons. Also, in rare cases, a child is born without testicles, leaving an empty scrotum.

While there is a wealth of information online about some of the medical conditions that may result in a need for testicular prostheses, there is little information about the use of implants in children and adolescent boys. For that reason we’ve posted some interesting links in the “Research and Links” section of this website. Three of the best sources are listed below.

American Pediatric Surgical Association
Authoritative site about pediatric surgery, including excellent information about undescended testes and the use of testicular implants.

Testicular prosthetic implants in boys and teenagers with primary or secondary anorchism
A journal article from the Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery (February 2008).

Testicular prosthesis insertion following testicular loss or atrophy during early childhood – Technical aspects and evaluation of patient satisfaction
A journal article from the Journal of Pediatric Urology (May 2007).

If you’ve browsed the different sections of this website, you’ve likely seen or clicked on a link to Straight Talk, our other site about sexual health, which includes information for men and women. While this site (testicularimplantinfo.com) is solely focused on testicular prostheses, the men’s section of Straight Talk covers a number of topics, including erectile dysfunction and urinary incontinence. This is a good place to visit if you’re interested in learning more about specific medical conditions and available treatments. The site also features a physician finder tool on the home page, which can help you locate an experienced physician in your area.

Other highlights include:

• Ask Ron and Gail, a contact form that allows visitors to send a question to a real couple that has dealt with and overcome erectile dysfunction.

• E.D. Self Assessment, an online quiz designed to help you identify potential signs of E.D.

• Medical Glossary, a collection of men’s health terms and their definitions – very helpful in preparing questions for your doctor.

• Information for Physicians - this part of the site contains technical information about specific devices and procedures, including product images and diagrams.

A reader recently asked about the presence of pain and discomfort after receiving an implant. As with most surgical procedures, patients experience an uncomfortable feeling or slight pain around the area of operation, but this typically goes away over time. In fact, the clinical trial we conducted found that discomfort was reported in 4.0% of patients, and pain was reported in 5.4% – for more information, visit the Appendix A section of the site.

Sometimes, as a natural reaction to any device placed in the body, scar tissue may form around a testicular implant. This is called a capsule. In some men, the capsule can contract, causing a condition known as fibrous capsular contracture. This can result in a hardening of the testicular implant, which may cause discomfort or pain. Fortunately, medical research has shown incidences of fibrous capsular contracture to be low in testicular implant cases.

As with any surgical procedure, it is very important to understand all of the possible risks and side effects. Please refer to the Risks and Complications page for a full listing.

As more and more people look online for reliable information, the growth of online communities (discussion forums, chat rooms, social networking sites, etc.) have helped form a broader conversation around complex, health-related topics such as cancer. One such community, the TC-Cancer Forum, is a site focused specifically on testicular cancer and related topics. The site also features a blog, external links, and various discussions, including active threads about treatment options and testicular implants.

Even with sites like TC-Cancer Forum, there remains a very limited amount of online information about testicular implants. We’ve tried to post as many links as possible on our Research and Links page, but please let us know if you’re aware of something helpful that isn’t on our list.

A urologist or other physician specializing in reproductive health is the best resource for information regarding testicular implants. However, before meeting with a specialist, be sure to review the information on this site so that you are well informed and able to ask specific questions. In addition to product and procedural information, it is very helpful to look at how different physicians describe the product, procedure, and rationale. Here’s some information to help you get started.

The Turek Clinic
The website of Dr. Paul Turek, a leading urologist in men’s sexual health. The site includes some good information about testicular implants and other topics related to men’s sexual health.

Dr. Turek also conducted an important clinical study of testicular implants, Safety and Effectiveness of a New Saline Filled Testicular Prosthesis, which was published in the The Journal of Urology (Note: You will have to create a free account to view the abstract and order the article).

To locate a specialist in your area, be sure to try our online physician finder.