Safety Considerations¹

Who is not a candidate for Solesta?

Solesta is only for patients aged 18 and over. People who have an infection or who are currently experiencing bleeding in the rectum or anus should not receive Solesta.

People who have problems in the rectum or anus, such as tumors, abnormal anatomy, large dilated blood vessels (hemorrhoids) or cracks in the tissue (anal fissures), should not receive Solesta.

People who have active inflammation of the bowels (Crohn’s disease or ulcerative colitis) should not receive Solesta.

People who have trouble fighting off infection (immunodeficiency disorder such as HIV/AIDS) or who take medication to suppress the immune system, such as those used in cancer or organ transplant patients, should not receive Solesta.

If you already have a device or a material placed in your rectum or anus, or if you have had radiation treatments in your pelvic area before, you should not receive Solesta.

You should also not receive Solesta if you have an allergy to any of the materials in the gel.

You should tell your doctor if you have any allergies or if you have had problems with your rectum or anus in the past. Your doctor will determine whether you are a candidate for Solesta.

What are the risks of Solesta treatment?

• Most treatment-related adverse events were experienced soon after injection with Solesta; the highest incidence occurred during the 48-hour interval following first injection¹

• 96% of the events required no intervention or required medical or simple noninvasive interventions¹

Most Common Risks¹

Mild pain or discomfort in rectum or anus, minor bleeding or spotting from the rectum, fever, diarrhea or constipation, abdominal pain. 

More Serious Risks (not common)¹

Infection*, Inflammation of the anus

*If you develop an infection (abscess) in your anus or rectum, you may need to have another minor procedure in your doctor’s office or in the hospital to treat the infected tissue. In this procedure, the doctor will make a small incision to relieve the pressure and infection, and then wash out the area.

If you experience any symptoms following treatment, such as bleeding from your rectum, bloody diarrhea, fever, inability or difficulty emptying your bowels or problems with urinating, you should immediately contact your doctor.

After the Solesta procedure

It is important that you take care of yourself following your Solesta treatment. Your doctor  may prescribe antibiotics for the chance that you may get an infection, or you may experience some minor bleeding following treatment. It is also possible that you might experience some mild pain or discomfort in the treatment area. As recommended by your doctor, take pain reliever medication if you feel pain or discomfort. By following some simple precautions (the DO NOTs listed below) you may be able to minimize these risks.

Post-Treatment Care¹

For the first 24 Hours (1 day) post-treatment, avoid:

• Physical Activity

• Hot baths

For the first week (7 days) post-treatment, avoid:

• Sexual intercourse

• Strenuous physical activity (e.g., jogging, bicycling, horseback riding, etc.)

• Antidiarrheal medication (stool softeners may be used until first bowel movement)

For the first month (30 days) post-treatment, avoid: 

• Insertion of suppositories or enemas and rectal temperature recording for one month

When to call your doctor

Contact your doctor’s office immediately if you experience symptoms such as bleeding from your rectum, bloody diarrhea, fever, and inability or difficulty going to the bathroom (emptying your bowel or problems with urinating).

Tell your doctor about your Solesta implants

It is also important for you to know that the Solesta gel might be detected during future medical examinations or during x-rays. Remember to tell other physicians who are taking care of you that you have received this treatment procedure with Solesta.

Learn more about results with Solesta