THE NOVAMED, VITEK AND BIOPLASTY CORPORATIONS
The Bioplasty Corporation was originally known as Genetic Laboratories, Inc. of St. Paul Minnesota. In the early eighties it became interested in the marketing of plastic surgery implants and considered the purchase of the accident-prone American Heyer Schulte production facility in Goleta, California. Bids for purchase of the breast and cosmetic surgery implant line were made. H However, the initial proposals were not followed through. A competing bidder ultimately purchased the American Heyer Schulte production plant and continues to distributes some of the original Heyer Schulte breast implant designs in the U.S. and abroad.
The name of Genetic Laboratories, Inc. was formally changed to Bioplasty Inc. In March 1988. The primary founders included Arthur Beisang and Robert Ersek, a plastic surgeon then practicing in Austin Texas. Ersek and several other plastic surgeons who had participated in late-eighties clinical trials of Bioplasty implants were major shareholders. The firm manufactured primarily saline-inflatable and gel-filled, smooth wall silicone implants. In 1990, it introduced textured surface implants with claims of reduced capsular contracture. The product is described in U.S. Patent 4,955,909 granted on September 11, 1990. This document alludes to textured surface technology as a mean of contracture control. It is credited to R. Ersek and A. Beisang and is assigned to Bioplasty Inc.
Product Lines:
Several other types of prostheses for cosmetic and reconstructive surgery were manufactured by Bioplasty between 1987-1992. The most widely used products were marketed under the name of Misti™. It is believed that about 6000-7000 units were sold worldwide, saline double lumen and smooth wall implants were sold in smaller numbers. The Misti™ implants were coarsely textured silicone shells with conventional silicone gel filling.
These products were generic analogs of commonly marketed items and were dependent on manufacturing processes similar to those used by McGhan/Inamed. This process required the dense shell surfaces to be supplementally coated with silicone elastomer dispersions of water-soluble substances such as sodium chloride. These overlays of silicone incorporating the water-soluble additives would then be subjected to water extraction and the sacrificial water-soluble material would dissolve to leave porous, bubble-like surfaces with large amounts of occluded elastomeric debris. The products used a variety of silicone-based raw materials including elastomer by Applied Silicone Corporation, Dow Corning Corporation, Rehau Chemical Corp. Distribution was primarily through contractors including Medical Products, Inc., CBI Medical and Medicor. Overseas distribution, mainly in Germany, also took place in smaller volume.
Substantially similar devices were made by other manufacturers in the U.S. and abroad via nearly identical processes. Bioplasty variants were presented to the FDA as 510K submissions circa 1989 and were claimed to be substantially similar to conventional non-textured devices. However, the promotional literature attributed unique tissue interacting characteristics to these surfaces. Claims included the absence of capsular contracture and superior aesthetic characteristics. The texturing process required repeated washing in aqueous solution and was prone to gross contamination by microbiological entities. The porous surface was fragile and released inflammatory debris into adjacent tissue. Adverse reactions, primarily of the low grade chronic infection type, were comparatively common.
Inamed/McGhan, a competing breast implant manufacturer from California, claimed patent infringement in November 1991 for the texturing process. In April 1992, the dispute was settled when Bioplasty paid Inamed $275,000.
Retrospective on Bioplasty Products, Clinical Trials and Distribution Practices:
Several surgeons with connections to the firm implanted large numbers of such devices. Some later published favorable reports on the products. Bioplasty later presented these routine cosmetic implantations with minimal follow-up as controlled investigational studies in FDA approval documents.
Medical removals occurred in large numbers from about 1991. Many patients required secondary debridement surgeries in order to retrieve prosthetic debris and capsule residuals from the initial removal attempts. Explantation of prostheses followed by separate dissection of the capsule such as is sometimes performed for smooth wall implants appears impractical for the textured Bioplasty products because of strong adhesion between capsular tissue and the shell surface. Few users retained the devices for more than five years and explantations have been primarily motivated by discomfort, deformity, deflation and pain.
The Late Bioplasty Era:
The FDA viewed Bioplasty products as investigational implants from the outset. In May 1991, they formally challenged the substantial equivalency classification (510k). The PMAs submitted by Bioplasty also failed to disclose earlier problems with the filling compounds used in the Misti Gold™; adverse reactions had been described from early synthetic plasma expanders (blood substitutes) based on similar formulae.
The FDA disputed the manufacturer's claims of radiolucency and minimal interference with mammographic diagnosis of tumors. The dispute surfaced publicly in 1991. The FDA rescinded the 510k Approval for the Misty ™ Gold and removed the product from the marketplace on July 30, 1991. The Moratorium on silicone gel prostheses later terminated the marketing of other Bioplasty products based on silicone gel filling materials. The company filed for Chapter 11 protection from receivership on April 1993. Very few users of its products were compensated for injuries, most of which were of disfiguring, infective and inflammatory nature.
NovaMed Inc, - Beyond Bankruptcy:
Marketing of residual Bioplasty products continued in Europe after 1993. The business was re-incorporated formally under the name of NovaMed (Europe) in 1994. With minor modifications, basically the same breast augmentation devices reappeared under the name of NovaMed. Still manufactured in Minneapolis, Minnesota, the Bioplasty Misty saline inflatables became the NovaSaline ™ and Misty Gold became the NovaGold™. The NovaSaline has been distributed in significant quantities in North America since the mid-nineties
Promotion continued at trade shows and plastic surgery conferences. Between 1996 and 1998 approximately 10,000 NovaMed implants were sold, mostly in Germany. The product was surrounded by the same claims as the Misty, including the previously rejected claims of safety for the PVP-based filler and radiolucency allowing cancer detection.
In 1999, NovaMed announced a Strategic Alliance with Inamed/McGhan for distribution of NovaGold and related Novamed products. An Investigational Device Exemption (IDE) was subsequently filed with the US FDA. The Corporations expects to begin clinical trials in the United States during the year 2000.
The Proplast Connection - Vitek, Dow Corning Wright and NovaMed:
NovaMed is believed to have been formed in 1988 incidental to a reorganization of Vitek Inc. The Vitek Corporation produced implants based on Proplast™, a controversial sponge-like Teflon-based material which disintegrated leading to disabling degeneration of articular joints. Vitek and Proplast™ later became issues in FDA Alerts and public media articles on Temporo Mandibular Joints (TMJ) adverse reactions.
Proplast™, a soft friable substance, was commercialized in the early seventies and used primarily in plastic surgery. Sold as blocks to be carved by surgeons and dentists according to needs, the product was used mostly to alter bony contours in cranio-facial surgery. In the late seventies, Dow Corning Wright became the principal distributor of Proplast. Preformed prostheses intended for articulations such as the TMJ became part of the product line circa 1978. Litigation soon followed, motivating the delisting of Proplast™ items from Dow corning Wright catalogs circa 1986. Following complaints by patients, the FDA inspected Vitek and NovaMed, issuing regulatory letters in 1989 and initiating seizures as late as 1992.
NovaMed, then a subsidiary of Vitek, was involved in manufacturing and distribution of Proplast™ items through a complex series of license agreements, patent assignments, foreign registrations and inventory transfers. Vitek Inc, NovaMed, Oral Surgery Marketing Inc, Tranquil Prospects Ltd/Hadaco Ltd (British Virgin Islands), Transjaw Inc, Dynamax Ltd and other Proplast-linked corporations were controlled by Dr. Charles Homsy of Houston, Texas.
NovaMed's operations in Houston were closed in 1992. However, it continues as a manufacturer of plastic surgery devices including breast implants. Its products are distributed mostly in Europe. Vitek filed for bankruptcy in June 1990, leaving a large number of injured patients without compensation. Dr. Charles Homsy is now a resident of Switzerland and is a prominent figure in the European plastic surgery products industry. In some quarters, the Vitek episode is likened to the Dalkon Shield IUD and A.H. Robins matters which had come into public view a decade earlier.
Late Developments:
On May 20, 1999, "Business Wire" announced an agreement between Inamed and NovaMed, granting exclusive marketing rights for NovaMed saline inflatables. This included the product NovaGold™, a variation on the saline inflatable filled with an aqueous solution of polyvinylpyrrolidinone (PVP). Inamed was to pay $8 million U.S. to NovaMed for the purchase and provide regulatory expertise and funding to obtain FDA approval for the NovaGold™ line.
On December 18, 2000, the Dow Jones Newswires reported the formal recall of NovaMed's NovaGold™ PVP-filled breast implants following a protracted dispute with the U.K. Medical Device Agency (MDA). The recall was ordered on or about December 11, 2000 with the release of an Alert Letter by the MDA followed by suspension of shipments of NovaMed products from Germany to the U.K. The recall was evidently initiated following NovaMed's inability to document safety and efficacy of its products to the satisfaction of the MDA in spite of about 200 patients having been implanted in the U.K. and several thousand implanted in North America prior to 1992. NovaMed's U.S. office said they would submit clinical trial applications to the FDA.
On December 22, 2000, the Dow Jones Newswires confirmed the resignation of NovaMed's directors with the exception of the president. The information was formally announced in a Securities and Exchange Commission filing.
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TMJD_SAFE_HAVEN_4_LIFE_ISSUES ยท TMJ SUPPORT GROUP
This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions.
This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes.
There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with.
It is YOUR place to cry, scream or vent on the pain you are dealing with and how it is affecting your life and the lives of your loved ones. The group is MODERATED to avoid the unsolicited advertisements and spam. We are all in pain and do not need to have to deal with that too.
TMJ SURGERY FAMILY!.
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