VITEK TMJ IMPLANTS

VITEK TMJ IMPLANTS

Teflon TMJ implants
Proplast/Teflon implants
Vitek-The Methodist Hospital Connection
Proplast TMJ implants
Vitek TMJ implants-A textbook case of
Vitek-Safety-Alert Legal Malpractice
Vitek-Legal Mal Practice

History:

How did Vitek devices get on the market?

FDA was given the authority to regulate medical devices in 1976, including TMJ implants.  Devices on the market before the laws were passed were �grandfathered�; that is, they were allowed to remain on the market.

Under the law, manufacturers can inform FDA that a product they plan to market is substantially equivalent to a product that was o the market before 1976.  FDA must then make the final decision about the equivalence.  If FDA decides that the new device is equivalent, it can be marketed.  In March 1983, Vitek notified FDA that it was planning to market the interpositional implant (IPI) to TMJ problems.  The firm claimed that it was substantially equivalent to an existing product, silicone sheeting, which was also used as a TMJ implant.  FDA agreed with the manufacturer�s claim of equivalence and the IPI device was allowed to be marketed.

The products were composed of a combination of materials with the composition changing over time.  To determine the composition of a patient�s implant, the patient may need to investigate hospital and doctor records.

Product                                    Composition

�Proplast� I, II                          Composite of polytetrafluorosthylene (PTFE) polymerized to  

or HA                                      Carbon (I), Aluminum Oxide (II) or Hydroxylapetite(HA)

IPI                                           Proplast I or II with polyamide or polyester fiber and teflon or
                                                 silicone or flourinated ethylene-propylene copolymer

VK                                          Proplast I or II with polyamide or metallic mesh.  Layer 2                                                            composed of nonporous polytetrafluoroethylene (PTE); or,                                                                    teflon or flourinated ethylene-propylene copolymer

 VK-I orV-1                             Condyle-Cobalt-Chromium-Molybdenum alloy with proplast o                                                         on the condyle fossa-polymide fiber and teflon or fluorinated                                                        ethlene-proplylene copolymer

VK-II or V-II                          Condyle-Cobalt-Chromium-Molybdenum alloy with proplast                                                            on the condyle
                                                Fossa-Proplast HA with ultra high molecular weight                                                              polyethylene (UHMWPE)

FDA - RECALL:

In March 1990, Vitek issued a safety alert to oral surgeons and consignees asking that they stop using the interpositional implant (IPI).  FDA notified the firm in May 1990 that according to the law this action in which the manufacturer either corrects the problem with the product or removes it from the market.

In October 1990, because Vitek continued to market TMJ products and surgeons were using the products.  FDA seized from this manufacturer and subsidiaries all TMJ products, including glenoid fossa, condyles, and any devices in the process of being manufactured.

In March 1991, FDA seized all articles and devices composed in whole or in part of Proplest including VK-1 and VK-II, chin, zygomatic arch, preformed facial sheeting and block material, plus all raw materials, and materials in process of being manufactured.

In June 1992, FDA ordered Novamed Incorporated and Oral Surgery Marketing, Inc., (subsidiaries of Vitek) to immediately contact all customers.  The firms were to notify the customers to cease distribution and use of replacement devices for the temporamandibular joint, VK, VK-I and VK-II and blocks and sheets of proplast used in weight-bearing positions in the body.  The firms were also ordered to contact all health professionals and device user facilities currently in possession of the devices and inform them of FDA�s order concerning the in the temparomandibular joint.  The firms made an inadequate effort to comply with this order.  FDA is continuing further regulatory action.

An FDA Safety Alert was mailed in December 1990 to all oral surgeons associated with the American Association of Oral and Maxillofacial Surgeons (AAOMS).  FDA also sent letters to professional organizations enlisting their help in notifying doctors of the symptoms, failure and recommendations concerning Proplast products.

VITEK TMJ IMPLANT RELATED INJURIES:

 Patients are experiencing a variety of problems.  These problems include:

VITEK-BANKRUPTCY
VITEK-CASE OF LEGAL MALPRACTICE
THE METHODIST HOSPITAL-THE MISSING DEFENDANT

VITEK CASES---THE MISSING DEFENDANT--THE METHODIST HOSPITAL 

By the time many patients with Vitek implants started having problems, Vitek had already begun it's bankruptcy proceedings.As a result many attorneys only filed a claim in the Bankruptcy case and did not file a legal action against another potential defendant, The Methodist Hospital . As a result many patients with Vitek implants were left with only a claim under the Bankruptcy distribution . In many of these cases the payments were a fraction of what might have been paid out if the claim had been filed against The Methodist Hospital also and in a seperate legal proceeding. In fact the failure to name The Methodist Hospital has been the source of a number of legal malpractice lawsuits.