Uniflate 1000®

What Was the Uniflate 1000?

The Uniflate 1000 was an inflatable penile prosthesis for the surgical treatment of severe erectile dysfunction.

It was made by Surgitek, Inc. and introduced in the 1980s.

It was a two-piece device: paired cylinders implanted in the corpora cavernosa, connected to a single scrotal component that served as both pump and reservoir, known as a resipump.

Surgitek introduced it at essentially the same time as Mentor introduced the GFS, and the two competed directly.

Both devices allowed transcutaneous resipump volume adjustment and both held a similar maximum fluid volume.

Surgitek's Place in Implant History

Surgitek was an active player in penile prosthetics during the 1980s.

In 1986 it launched the Flexi-Flate, a one-piece self-contained inflatable implant composed of two hydraulic cylinders with no parts outside the penis, released the same year as the AMS Hydroflex.

A revised Flexi-Flate II followed, and the Uniflate 1000 arrived as the company's two-piece entry, with its surgical procedural guide dated 1989.

Surgitek is no longer manufacturing or marketing penile prostheses.

If you have a Surgitek device of any kind, there is no company to contact about it.

The Dual-Chamber Cylinder

This is the design feature worth understanding, because nothing else on the market worked this way.

The Uniflate cylinders had two layers: an outer silicone layer and an inner Dacron layer.

Those two layers created two chambers within each cylinder.

The inner chamber provided rigidity in the conventional way.

The outer chamber added further girth to the cylinder.

The intent was to address the central weakness of every two-piece implant, which is that a small scrotal reservoir cannot deliver the girth expansion a large abdominal reservoir can. Splitting the cylinder into two chambers was an attempt to get more apparent girth out of the same limited fluid volume.

The Self-Sealing Fill Port

The Uniflate resipump carried a self-sealing penetrable port on its underside.

The device was filled through that port.

It also meant fluid volume could be adjusted transcutaneously after implantation, without opening the scrotum.

The competing Mentor GFS also allowed office-based fluid adjustment, but through a different mechanism.

For a surgeon in that era this was a practical advantage: an implant that lost a little volume, or a patient who needed slightly more, could sometimes be managed in clinic rather than in theatre.

Preassembled, Prefilled and Trimmable

The Uniflate 1000 was supplied preassembled and prefilled, with a trimmable tail.

Preassembly matters in a hydraulic implant, because every connection made in theatre is a potential leak point.

The trimmable tail allowed the surgeon to adjust proximal length to the patient's corporal measurement.

Contemporary reviews note that the Ambicor, which succeeded this generation of devices, is more difficult to implant than historical two-piece implants such as the Uniflate 1000.

Ease of implantation was a genuine strength of the device.

Tubing Fracture

The Uniflate's characteristic failure was fracture of the tubing.

Tubing fracture emerged as a persistent issue and contributed to mechanical failures.

This is the same category of problem that drove Mentor to remove the connectors from the GFS and produce the connectorless Mark II, and that eventually pushed the whole industry toward preconnected components.

A man whose Uniflate stopped inflating, or that inflated and then would not hold, was most likely experiencing a tubing failure with loss of fluid.

Regulatory Failure

The Uniflate 1000 did not obtain FDA approval.

Despite its promising features, the device failed to secure approval from the US Food and Drug Administration.

This is the decisive fact in its history, and it separates the Uniflate from the Mentor GFS and Mark II, which were marketed in the United States and later withdrawn on clinical grounds.

Verification note for the editor: the literature is not fully consistent here. Implantation series exist, including one of 84 patients, and the device appears in surgical procedural guides and museum collections, which suggests clinical use during an investigational or pre-approval period. Before publishing, decide whether to state the FDA position as flatly as the source does or to add a qualifier.

The Evidence Base Is Very Thin

This needs stating plainly rather than dressed up.

The largest reported Uniflate series, 84 patients reported by Barrett in 1989, appears in a Surgitek clinical market study rather than in a peer-reviewed journal.

Manufacturer market-study data is the weakest form of clinical evidence there is. It is not independently reviewed, its methodology is not published, and it exists to support sales.

Independent mentions of the device in the peer-reviewed literature are incidental. In one series on implantation in corporal fibrosis, a single patient's Uniflate failed two years after surgery and was replaced with a Mentor Alpha-1.

There is no long-term device survival study for the Uniflate 1000 comparable to what exists for the Mentor devices.

Any page that presents confident reliability statistics for this implant is inventing them.

How Patients Operated the Device

The patient squeezed the scrotal resipump to move fluid into the cylinders.

The penis became rigid.

A release mechanism returned fluid to the resipump.

As with all two-piece implants, the deflated state was not truly flaccid, because residual fluid remained in the cylinders.

There was no abdominal or pelvic reservoir.

Uniflate 1000 vs Mentor GFS

These were the two competing two-piece implants of the same moment.

Both used paired cylinders and a scrotal resipump.

Both allowed transcutaneous adjustment of resipump volume, and both held a similar maximum fluid volume.

The GFS cylinders expanded to a fixed girth and came in two width sizes. The Uniflate instead used dual-chamber cylinders with an outer girth chamber.

The GFS reached the US market and generated published outcome data. The Uniflate did not secure FDA approval and generated almost none.

Uniflate 1000 vs Mentor Mark II

The Mark II was Mentor's answer to the reliability problems of the first-generation two-piece devices, and its defining change was the removal of tubing connectors.

The Uniflate's persistent problem was tubing fracture.

Both devices were, in different ways, defeated by the same underlying engineering challenge: keeping a low-volume hydraulic system leak-free inside a body for decades.

Both were discontinued.

Uniflate 1000 vs Flexi-Flate

Both were Surgitek products but they are different classes of implant.

The Flexi-Flate, introduced in 1986, was a one-piece self-contained device with two hydraulic cylinders and no components outside the penis.

The Uniflate 1000 was a two-piece device with a separate scrotal resipump.

If your records simply say "Surgitek implant," the distinction matters: a self-contained device has nothing in the scrotum, while a Uniflate has a scrotal component.

Uniflate 1000 vs Ambicor

The Ambicor is the only two-piece inflatable still available and is the modern equivalent of this device class.

AMS introduced it in 1994 with prefilled and preconnected components.

It is harder to implant than the Uniflate was, but it is supported, regulated and backed by contemporary outcome data.

Any man who wants the two-piece concept today is looking at an Ambicor, not a Uniflate.

Uniflate 1000 vs Three-Piece Implants

A three-piece implant places a much larger reservoir in the abdomen or pelvis.

That extra fluid produces greater girth expansion, genuine flaccidity when deflated, and a reserve that accommodates changes in the corpora over years.

The Uniflate's dual-chamber cylinder was a clever attempt to compensate for a small reservoir. The market's verdict was that it did not compensate enough.

Three-piece devices such as the Coloplast Titan and AMS 700 dominate the market today.

If You Already Have a Uniflate 1000

This is the situation most readers of this page are in.

A Uniflate implanted around 1990 is now more than three decades old.

The device is out of production, the manufacturer has left the field entirely, and no cylinders, tubing or resipumps exist.

No warranty is in force and no repair is possible.

If it still inflates, deflates and produces a usable erection without pain, there is no automatic need to remove it.

If it has failed, leaks, will not hold pressure, has become painful, or shows any sign of erosion or infection, it needs urological assessment.

Identifying an Unlabelled Old Implant

Many men with implants this old have no operative records.

A urologist can often identify the general class of device from examination and imaging: whether there is a scrotal component, whether there is an abdominal reservoir, and how the cylinders behave.

Distinguishing a Uniflate from a Mentor GFS on imaging alone is not always possible.

In practice this rarely changes management, because every discontinued two-piece device is handled the same way: assess, and remove or exchange if it has failed.

Revision and Replacement Surgery

Replacing a decades-old prosthesis is not the same operation as a first implant.

Scar tissue forms around implanted cylinders over time and can restrict corporal space.

Removal of the old device and placement of a new one is usually performed in a single operation where tissue conditions allow.

Corporal dilation, scar excision or downsizing to narrower cylinders may be required.

Where fibrosis is severe, a malleable implant may be the only device that can be placed safely.

Explantation Without Replacement

Some men choose removal without a new implant.

Erectile function does not return after explantation.

Removing cylinders from scarred corpora typically results in shortening and permanent loss of erection.

Where a device is removed for infection, delayed reimplantation is generally harder than immediate exchange.

This decision deserves an unhurried conversation with an implant surgeon.

Does the Uniflate Restore a Natural Erection?

No.

Like all penile prostheses, it produced mechanical rigidity.

It did not restore arterial inflow, veno-occlusion or cavernous nerve function.

It did not affect libido, sensation, orgasm or ejaculation, which depend on nerves and hormones rather than on the erectile mechanism.

Does the Uniflate Increase Penile Size?

No.

The dual-chamber design was intended to improve girth expansion relative to other two-piece devices of its era, not to enlarge the penis beyond its own dimensions.

Cylinder length was matched to the corpora using the trimmable tail.

No penile prosthesis is a lengthening device.

MRI and the Uniflate 1000

Flag for verification before publishing. No manufacturer MRI conditions statement exists for the Uniflate 1000, and no successor company can issue one.

Recommended page wording: patients with a Uniflate 1000 should inform radiology staff of their implant before any MRI scan, and the radiologist should assess the device individually. Note that the cylinders contain a Dacron layer as well as silicone, which the radiologist should be told.

Do not state or imply that the device is MR Conditional or MR Safe.

Regulatory Status

The Uniflate 1000 failed to secure FDA approval and is not approved or supplied in any market today.

Surgitek no longer manufactures or markets penile prostheses.

Men seeking a penile implant today will be offered a currently regulated device.

Warranty

There is no warranty.

Surgitek has left the penile prosthesis market, the device is discontinued, and no manufacturer replacement programme applies.

Any surgery involving an existing Uniflate is treated as revision surgery and priced accordingly.

Why This Page Exists

The Uniflate 1000 cannot be chosen by anyone today.

It matters for two reasons.

First, men still carry these devices and need accurate information when one fails, particularly because no manufacturer exists to answer questions about it.

Second, its dual-chamber cylinder was a genuinely inventive attempt to solve the two-piece girth problem, and the fact that it still did not survive tells you how hard that problem was.