asked questions

Bulkamid is injected into the walls of your urethra and does not involve incisions or cuts into the skin or vaginal wall which may be required with other operations for stress urinary incontinence. Bulkamid is usually done under local anaesthetic, in which case you will be awake and may feel a sting. You can discuss the anaesthetic options with your doctor.

There have been no long-term complications reported from more than 70,000 women who have been treated with Bulkamid5. As with any procedure, short-term complications may happen. However, these normally resolve within a couple of days after your treatment. These can include mild pain after the procedure, difficulty emptying your bladder, urgency (the sudden urge to urinate), urinary tract infection, mild burning or bleeding when urinating7.

Usually women can return to normal activities within 24 hours of the procedure, although heavy lifting, hard physical exercise and sexual intercourse should be avoided for up to 2- 3 weeks.

Yes, Bulkamid has been used to treat stress urinary incontinence in women who have undergone previous midurethral slings8.

If Bulkamid does not reduce your stress urinary incontinence symptoms enough, you may need a further top up injection. This is usually done within the first year following the initial procedure. If after your top up you feel Bulkamid is not for you, you can discuss other treatment options with your doctor. Having Bulkamid does not mean you cannot then have other treatments.

There are many treatment options available for stress urinary incontinence including pelvic floor muscle training and lifestyle changes. This should be tried before further treatment options are considered. However, in many patients these do not make a meaningful difference to your symptoms. Besides Bulkamid, other more invasive surgical options are available – view the treatment options table here. All options should be discussed with your doctor.

Plastics are synthetic materials (usually solid) made from a wide range of organic polymers such as polyethylene, polypropylene, PVC, nylon, etc., that can be molded into shape while soft, and then set into mostly rigid objects. Plastics possess a significant resistance to deformation, which in turn can cause stress in the interface between the solid plastic and the surrounding soft tissue, thus inducing  deformations of the native tissue. It is this rigidity that is thought in some cases to cause problems with mid-urethral tapes in terms of tape erosion and possibly pain.

Bulkamid is a hydrogel. Hydrogels are soft materials composed of one or more polymers consisting mostly of water. The Bulkamid Hydrogel consists of 97.5% water and 2.5% cross-linked polyacrylamide. All plastics are polymers, but not all polymers are necessarily plastic. Obvious examples of polymers not being plastic are polysaccharides and polypeptides. Hydrogels are easy to deform with practically no resistance to deformation with body movements, and their mechanical properties are compatible with native soft tissues and organs.

Over the last 18 years, Contura has extensively studied and evaluated the safety of the Bulkamid hydrogel, in full accordance with numerous international regulatory authorities’ requirements.

As part of Contura’s routine Quality Assurance release for every batch of Bulkamid produced, a number of tests are performed to ensure product compliance with high quality and safety standards. The release specification for the trace amounts of residual acrylamide monomer in Contura’s polyacrylamide hydrogels, as approved by regulatory authorities, has been set at a safety level of 1.5 µg/mL. Typically, the acrylamide levels in batch testing are much lower (< 0.6 µg/mL). This level of acrylamide in Bulkamid equates to almost 1000 times lower than the lifetime daily dose limit as established by the US Environmental Protection Agency and other international authorities.

Contura therefore confidently concludes that the maximum possible exposure to acrylamide is negligible and gives no increased health risk to patients injected with Bulkamid.

A variety of materials are commonly and safely used in medicine. Their safety and effectiveness depend on many factors which include quantity, intended use, placement as well as their physico-chemical characteristics and manufacturing process. Each of these parameters has a significant effect on safety and performance. Polyacrylamides differ considerably in their chemical and physical structure and hence their use cannot be commonly considered as the same.

Bulkamid is a hydrogel consisting of 97.5% water and 2.5% cross linked polyacrylamide. Manufactured at our facilities in Copenhagen, the process has been established over 20 years and inspections from international regulatory authorities take place regularly to ensure compliance and robust standards are maintained.

Safety in the body has been established through comprehensive biocompatibility and clinical testing in accordance with international and national regulations (EU and US) that are relevant for this class of device. Bulkamid is a Class III device in the US that is subject to a rigorous premarket clinical investigation and regulatory approval pathway. In comparison mesh products for urinary incontinence surgery are Class II devices in the US and undergo a less rigorous regulatory process.

Given the standards and testing that has been in place and the clinical experience over the last two decades, Bulkamid’s safety has been well established.

For a detailed list of biocompatibility testing requirements, see FDA guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.

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