Open Letter to the Dental Profession
FDA REGULATION OF THE DENTAL IMPLANT INDUSTRY
As we enter the 1990s, the Implant Industry promises to become an increasingly important part of your practice, offering both financial rewards for you and benefits for your patients. Once again, Core-Vent Corporation finds it necessary to set the record straight regarding issues that affect the field of Implantology. Your ability to make informed decisions is compromised by the dissemination of false and misleading information. The enclosed information will address the following issues:
1. FDA Regulatory Compliance –– Core-Vent’s response to Nobelpharma’s "negative marketing" practices.
2. FDA Premarket Approval –– Nobelpharma and the Swedish Trade Council vs Dental Implant Manufacturers Association –– Impact on future implant and abutment options and costs.
3. Bias and Misleading Articles –– Impact on scientific progress and the FDA’s evaluation of the need for PMA studies.
Gerald A. Niznick, D.M.D, M.S.D
President, Core-Vent Corporation
EXERPTS FROM A MEDICAL DEVICE TRADE PUBLICATION:
November 17, 1989 Devices & Diagnostics Letter Page 4
Possible Failure To File 510(K)S Charged To Firm
FDA says Core-Vent, Encino, Calif., deviated from manufacturing specifications for its dental implant and apparently failed to submit 510 (k)s for the second stage of the implants for the firm’s Screw-Vent, Swede-Vent and Micro-Vent, for bone-cutting instruments and drills and the electric motor/physio dispenser.
The company also may be required to file a 510 (k) for the use of demineralized freeze dried bone for use during installation of endosseous implants, the agency said in a Regulatory letter. It said Core-Vent may be promoting the use of such bone graft material, though it was not mentioned when it previously submitted a 510 (k) for its endosseous implants.
Good Manufacturing Practice violations alleged against the company included acid etching Swede-vent implants for 30 seconds when the written procedure limited the time to 10 seconds. The Regulatory Letter also charged that Core-Vent failed to submit Medical Device Reports after learning of malfunctions in at least four cases.
November 24, 1989 Devices & Diagnostics Letter Page 5
Firm Believed Implant Heads Already Covered by 510 (K)
Core-Vent, Encino, Calif., told by an FDA Regulatory Letter that 510 (k)s may be required for the second stage –– or "head" –– of several dental implants, is responding that it believed it had received approval of that stage for all its implants when it filed a 510 (k) for its newest product, the Bio-Vent. The same head fits all of its implants, the company said.
But, if separate 510 (k)s for the head are necessary for the Screw-Vent, Swede-Vent and Micro-Vent implants, the firm will comply, Core-Vent’s president, Gerald Niznick, told D&DL. He said the FDA just started viewing the head, screwed into the implant in a second stage process, as part of the device in 1987.
Offering comments on an article on Regulatory Letter charges (D&DL, 11/17, page 4), Niznick also said Core-Vent did not submit Medical Device Reports on four malfunctions because they did not involve serious injury and the malfunction rate was below the expected level cited in the labeling.
And, on an FDA allegation that, when the firm etched Swede-Vent implants for 30 seconds instead of the maximum 10 seconds called for in the specifications, it violated Good Manufacturing Practices. The firm said the procedures were written to allow 10 seconds to a minute for etching, the same as for its other implants. Niznick said that he will work with the FDA to resolve all issues raised.
CORE-VENT’S RESPONSE TO NOBELPHARMA’S LETTER
ON FDA ACTIVITIES
In a calculated effort to promote its own products by casting aspersions on Core-Vent Corporation, its most successful competitor, Nobelpharma USA has been circulating copies of an FDA Regulatory Letter received by Core-Vent Corporation in November, 1989. The background to this incident is clearly explained in the attached excerpts from a medical device trade publication (Devices & Diagnostics Letter, November 17 and 24, 1990). Although Nobelpharma understandably chooses not to mention it, the substantive issues raised by FDA have all been addressed by Core-Vent Corporation. Furthermore, other than awaiting approval of the requested 510 (k) applications, we have been advised by the FDA that its files on this matter have been formally closed. The simple fact is that Core-Vent has never been subject of FDA regulatory enforcement action. Nobelpharma’s recent effort to "smear" the reputation of Core Vent products demands a factual response.
Mr. William Ryan, President of Nobelpharma USA, stated in a letter dated January 17, 1990 to select educators and Nobelpharma System users in this country and abroad, that his company’s last FDA inspection resulted in "no negative remarks." Mr. Ryan’s comments appear to be misleading because any FDA inspection of its US facilities would, of necessity, be limited to a review of paperwork associated its distribution and marketing activities in the US. In order for an FDA review of Nobelpharma’s manufacturing activities, the FDA would have to travel to Nobelpharma’s Swedish manufacturing plant. While Nobelpharma has been selling implants in the USA since 1983, it was not until May, 1989 that the FDA finally went to Sweden to inspect their manufacturing and packaging facilities. Nobelpharma Sweden was left a post-inspection FDA form 483 that contained ten negative inspection observations relating to sterile controls, labelling and response to complaints. To put this into perspective, it should be noted that Core-Vent’s most recent inspection in May 1989, the findings of which Nobelpharma has been spreading throughout the profession, resulted in a post inspection FDA Form 483 containing only nine negative inspection observations. One of Nobelpharma’s alleged violations of Good Manufacturing Practices related to 73 complaints in a seven-month period. Their May, 1989 inspection stated:
Complaints are not routinely documented with reason for not conducting investigations, e.g. 24 of 73 complaints since 10/88.
The FDA supervisory comments of the Nobelpharma inspection report prepared after their May, 1989 inspection states:
The firm may require written notice from IPTSB of the need to correct the discrepancies (sic) and product may have to be refused entry into the US.
According to Regulatory Affairs, Vol. 2, Spring 1990, "foreign firms are given advance notice of their upcoming inspection and the amount of inspection time actually spent in each plant is usually less than most domestic inspections." In spite of these advantages, Nobelpharma, during the 1989 plant inspections, still had more negative observations than did Core-Vent. While neither Core Vent’s or Nobelpharma’s 1989 inspection reports is a performance that the respective companies should be proud of, and we assume that Nobelpharma has instituted appropriate corrective action in Sweden as we have in the USA, the fact remains that Nobelpharma is scarcely in a position to cast itself as the shining leader of the industry in matters of FDA regulatory compliance. Nobelpharma, when informed that Core-Vent was in possession of copies of their first and only FDA inspection (1989), wrote threatening that, if they "learn that Core-Vent is distributing copies of FDA communications pertaining to any of Nobelpharma’s facilities," they would further distribute Core-Vent’s 1989 inspection report and even reports from previous years.
ONCE AGAIN NOBELPHARMA UNDERESTIMATES CORE-VENT’S RESOLVE TO BRING THE FACTS TO THE PROFESSION AND NOT BE INTIMIDATED BY THEIR "NEGATIVE MARKETING" TACTICS.
There are a number of other important areas where the ongoing performance of Nobelpharma, in our opinion, potentially raises significant regulatory compliance issues that the profession may not be aware of:
1. 510 (k) PREMARKET NOTIFICATIONS: Nobelpharma has taken pains to point out in letters to the profession that Core-Vent was taken to task by the FDA for failing to file certain 510 (k) submissions for some of its abutments. We believe that our 1988 Bio-Vent 510 (k) filing had covered those abutments since the abutments are essentially the same for all of our implants. This was pointed out in our Bio-Vent application and our other implants were specifically cross referenced in that application by their 510 (k) numbers. Core-Vent, nonetheless, has submitted additional 510 (k)s for those abutments. Nobelpharma, according to FDA records, has not filed a single 510 (k) since 1984.
A. NO 510 (k) ON NOBELPHARMA’S NEW PROSTHETIC ABUTMENTS: In 1988, Nobelpharma introduced a new Single Tooth Abutment and in 1989, a new Angled Abutment. Pages 16 & 17 of their catalog indicate new components for new applications compared to the standard abutment that was in use in 1984 when Nobelpharma filed its 510 (k) marketing application. Although the new angled abutment utilizes a different method of connection to the implant than the standard Nobelpharma abutment, that could affect stability (a double hex with 12 points broached in their mating surface allows a 30 degree rotation instead of the traditional 6 sides of a hex), no additional 510 (k) premarket notifications have been submitted by Nobelpharma. A published article by Ohrnell, Brånemark et al., on single tooth applications with the Brånemark fixture (Quintessence International, Vol. 19, 1988) acknowledged "loosening of the center screw, leading to a loose abutment and rotation of the crown". The article recommended a modification to the implant itself, extending the height of the hex to 1.2mm from the current 0.7mm to increase the interdigitation. In light of this, and the fact that the "double hex" base of the new Angled Abutment may provide even less interdigitation than the standard abutments, it would certainly appear that an FDA review of a 510 (k) submission prior to marketing would have been prudent.
B. NO 510 (k) ON NOBELPHARMA’S NEW CONICAL SELF TAPPING IMPLANT: In 1988, Nobelpharma introduced a Conical Self-Tapping Fixture which, it is now apparent, represents a significant change from the original Brånemark fixture cleared in Nobelpharma’s 1984 510 (k) application. This is evident by the fact that Canadian customers (but curiously not American customers) were recently warned in writing by Nobelpharma that the Conical Self-Tapping Fixture (with its 4mm neck) should "not be used for other than bone grafted cases or unacceptable bone loss may occur." This rather dramatic new restriction in the indications for this product was not present when the original Brånemark design was cleared by the FDA in 1984. This may well require the filing of a new 510 (k) notice due to the acknowledged differences in the safety and effectiveness of this new design. In Core-Vent’s opinion, the "unacceptable bone loss" reported with Nobelpharma’s new Conical Self-Tapping Fixture is the result of too long a neck, especially without the benefit of sufficient surface micro pitting created by acid-etching or HA coating. Nobelpharma might be advised to inform their American customers and the FDA of the potential problems with this implant when used in other than bone graft cases where bone loss is expected.
2. THE "CUSTOM DEVICE" LOOPHOLE: The FDA exempts "custom devices" from such regulatory requirements as filing of 510 (k) premarket notifications, and defines such devices as one manufactured to meet the unique and special requirements of a physician or dentist, or those of his patients. Nobelpharma apparently has interpreted this regulatory loophole in such a way that its small diameter implants (3.0 mm) are being sold to dentists through Nobelpharma’s "Custom Design" department, rather that securing a 510 (k) marketing clearance for the product. The 3.0 mm diameter Brånemark fixtures sell for $240 each ($70 more than their standard fixtures) and are available pre-packaged in 7mm, 10mm and 13mm lengths with appropriate article numbers for re-ordering. Nobelpharma also sells new abutments for the 3.0 mm implants for $212, which is about $100 more than their standard abutments. This new implant design, therefore, may not be a "custom device" as that term is defined by the FDA, and would not be exempt from 510 (k) clearance prior to distribution. The 3.0 mm diameter implant and its smaller abutment may be particularly unsuited for continued distribution by Nobelpharma in this fashion, given the fact that a Nobelpharma newsletter to its customers noted that the 3.0 mm fixture is 50% weaker than the standard 3.75 mm diameter fixture, raising significant questions about its safety and effectiveness in clinical use. The abutments for the smaller diameter implants may be weaker than Nobelpharma’s standard abutments, which are already 30% weaker than the Swede-Vent Abutments (Ohio State Study). An article by Amerian Sones on the complications with the Brånemark System (JPD, Nov. 1989, Vol. 62, No. 5, Page 582) reported that "Of particular concern is abutment screw fracture, which can be a serious problem (Fig. 5)...if the fractured abutment screw is buried within the internal threads of the fixture, it may be un-retrievable." Given this article reporting breakages that render the implant useless, it would stand to reason that the new abutments for the smaller implants are potentially weaker and could result in even greater breakage. If Nobelpharma would consider using titanium alloy, as is used in the Micro-Vent and Bio-Vent Implants, instead of pure titanium, they could also provide a small diameter implant with adequate strength, as well as eliminate most, if not all, of the breakages reported with their standard diameter implant. As Dr. Franklin Young, Profession and Chairman, Dept. of Materials Science, Medical University of South Carolina, stated in his presentation at the NIH Consensus Development Conference on Dental Implants:
Commercially pure titanium has barely adequate (perhaps inadequate) mechanical properties for dental implant applications, and while it is a logical starting material, unalloyed metals are not usually found to be optimum.
3. MEDICAL DEVICE REPORTING (MDR): In Nobelpharma’s communications to the profession, it publicized that the FDA had questioned Core-Vent’s decision not to file an MDR for four of its implants, three of which had simply lost osseointegration. As members of the profession may be aware, MDR reports are generally required to be filed with the FDA whenever it comes to a company’s attention that one of its products may have been associated with a serious injury. Those members of the profession reading the Nobelpharma communications might erroneously assume that Nobelpharma, itself, is a paragon of regulatory virtue when it comes to MDR reporting. There is no record that Nobelpharma has ever filed a single MDR report with the FDA, despite the fact that a number of fractured implants have been reported to them, as well as a higher than usual number of failures of 7mm long implants in the maxilla. Furthermore, in an article published in the Journal of the California Dental Association (Mito, et al., J Calif Dent Assoc 1989;17:12-17,), the UCLA Implant Team reporting on its experience with the Brånemark fixtures documented that, while all of the maxillary implants followed for 24-36 months had initially achieved osseointegration, 25% of those eventually lost osseointegration. Without Nobelpharma properly warning the profession of the expected incidents of the loss of osseointegration, fracture of implants or fracture of abutments, it has been the FDA’s position that these types of failures be reported to the FDA through the MDR process.
Higher Than Usual Failure Reported With Nobelpharma 7 mm Implant: One dentist claims to have reported to Nobelpharma 50% failure with the Brånemark 7 mm fixture in the maxilla and was told, according to his statement under oath, that this was not uncommon. MDRs serve the purpose of indicating failure trends so that the dentist can provide the proper informed consent to his patients, or stop using a product that is not predictable. One explanation for this higher failure rate is the wider neck, which requires countersinking, removing supporting cortical bone on the crest of the ridge. In addition, according to the published studies of Brånemark (1977 Textbook) and Zarb (JOMI, 1987, Vol. 2, #2,), an additional 1.5 mm of bone loss, as measured from the base of the countersink, will occur in the first year of function. This is most likely due, according to Brånemark (1977 Textbook, Page 109), to "high stress concentration in the marginal region" from the wider neck being "pressed into the bone site entrance" during installation. In addition, the Brånemark fixture has no threads on the apical 1.0 mm of the implant so, after one year in function, only about 2.5 mm of the length of the threaded body provides anchorage into the bone. The 7mm length is also too short to allow an apical vent for bone ingrowth, providing anti-rotational resistance. Even if this implant osseointegrates with only 2mm to 3mm of length contacting the bone, the long-term predictability is questionable. Based on these facts, we invite Nobelpharma to ascertain the extent of the failures and make the FDA and profession aware of the results. If the failure rates reported by some individuals for the 7mm Brånemark Implant prove to be widespread, Nobelpharma would be advised to recall it or inform their customers of its limitations.
The Swede-Vent 7 mm fixture matches the Brånemark 7 mm fixture in design, material and dimension. Core-vent Corporation is advising its customers not to use the 7 mm Swede-Vent fixture in the maxilla and, instead, is recommending a new 8 mm Conical Self-Tapping Swede Vent Fixture, which now has the type of short conical neck, apical threads and vent that has proven so successful with the Screw-vent Implant. The implant does not require countersinking in the maxilla because its gentle sloping neck can expand the bone. Using Swede Vent’s new flat-bottomed spade drill, the 8 mm Swede-Vent can be inserted in the same depth of osteotomy as was required for the placement of the 7 mm fixture when using a conventional drill with a pointed end, thus adding 14% more surface area for support.
4. LABELLING ACCURACY: FDA labelling requirements mandate that product labelling not be false or misleading. In light of this clear and unambiguous requirement, it is interesting to note that Nobelpharma states in its product catalog that "the titanium components and disposable instruments are guaranteed to be clean, sterile and free from contamination." A 1987 metallurgical report examining Nobelpharma implants, which was itself funded by Nobelpharma, paints a dramatically different picture. The Taussig report (#74305-1/August 27, 2987) documented particles of tin, lead, iron, and aluminum trapped in the folds of the machined titanium surface and stated, contrary to Nobelpharma’s labelling, that "Brånemark implants exhibited evidence of nonmetallic particles on the surface of the implants while the implant had been sealed in glass containers." The report went on to note that "Even though the implants have been rendered biologically sterile, the contamination of the metal surface by metallic particles had resulted in the implants not being sterile from a metallurgical point of view." The report also stated, "It is our opinion that the metallic particles and nonmetallic particles that we observed on the Brånemark Implant surfaces, as well as the numerous areas where the apparently ground surfaces have been folded over, are not metallurgically satisfactory and can detract from the suitability of the implants for service." The metallurgist recommended that Nobelpharma take steps to see that the titanium surface be passivated (acid washed) "to eat out any metallic particles and to help reinforce the passive oxide film on the surface of the titanium." Although Nobelpharma has yet to act on this suggestion, Core-Vent instituted acid-etching of its implants in 1986. Subsequently, we hired the same laboratory to evaluate our implants. The report summary stated that the Core-Vent implants "in our opinion, appear to be metallurgically improved over that of the Brånemark Implants previously examined for Nobelpharma by our laboratory."
Despite Nobelpharma’s persistent and misleading effort to cast aspersions on our U.S.-made implant products through the distribution of a single FDA letter, while at the same time conveniently ignoring the problems associated with its own foreign-made implant products, as set forth in this response letter, we believe that American dentists cannot be so easily fooled . We challenge Nobelpharma to compete with us fairly in the marketplace, based on product versatility, quality, customer service, and price –– rather than on who can make the most accusations! We regret having to burden members of the dental profession with this response letter, but felt compelled to bring the truth to your attention in light of some of the misrepresentations which have been made.
RESPONSE TO NOBELPHARMA’S LETTER IN FDA PREMARKET APPROVAL
On February 27th, 1990, Nobelpharma widely circulated a letter to the profession claiming to state where "Nobelpharma stands as the dental implant industry faces increasing regulation by the Food and Drug Administration." This letter quotes a statement that Nobelpharma incorrectly claims is from a page of "a petition by the Dental Implant Manufacturers’ Association (DIMA)" to the FDA. While DIMA has filed a petition to reclassify endosseous implants to the same category as many orthopedic implants, the quote is actually from a letter DIMA wrote to the FDA objecting to a proposal by the Swedish Trade Council of the Swedish State Department. Nobelpharma and the Swedish Government are strongly advocating that the FDA proceed with the Premarket Approval process (PMA) that could cost the American dental implant manufacturers, and ultimately the American dental profession and public, tens of millions of dollars. One of the arguments made by the Swedish Trade Council in their petition is:
To compare the endosseous dental implant with Class II devices such as artificial shoulder, knee, wrist, ankle and hip prostheses is irrelevant. The entire system of the endosseous dental implant, including the abutment, is a soft tissue penetrating device.
This is a specious argument because treatment of complications with dental implants, which project into the oral cavity, is much less invasive than the treatment of orthopedic implant failures. The inside cover of the Brånemark, Zarb, Albrektsson Textbook, Tissue-Integrated Prostheses (Quint. Pub., 1985) clearly attributes no significance to the fact that dental implants are "soft tissue penetrating devices":
In the past, implant failures have been attributed to the epithelium’s apparent inability to predictably seal in the implant’s transepithelial contact area. This book suggests that the nature of the epithelium around the implant may be of academic interest only.
The Premarket Approval process, called for by the FDA by 1992, will require all implant manufacturers to provide clinical studies according to a proposed set of guidelines. In Sweden, the government pays for treatment with Nobelpharma implants –– other implant systems are excluded. Therefore, Nobelpharma’s Swedish clinical studies have been financially subsidized by the Swedish Government. American implant manufacturers, on the other hand, will have to fund their own clinical studies to meet the PMA guidelines. For those companies still able to sell their implants after the 1992 filing deadline, there will be little incentive to develop new products as three-year studies would have to be conducted before they could be marketed. Nobelpharma is also advocating that abutment companies be regulated the same as implant manufacturers. Companies offering compatible abutments to the Nobelpharma implant, many of which are more cost effective, stronger or more versatile than Nobelpharma’s, may be faced with prohibitive research costs exceeding their gross annual sales. The FDA’s proposed guidelines appear to require separate studies of 100 patients for each location in the jaw and each prosthetic application for a total of up to 600 patients per implant design. The economic impact of this, especially for companies offering a variety of implant designs and materials, can be related to two government sponsored studies: one at Harvard where one blade implant was placed in each of 50 patients at a cost of $2,000,000, and a V.A. study of 150 patients, also with blade implants, which cost the taxpayers almost $6,000,000.
A vast number of published articles have been submitted to the FDA demonstrating the clinical success and predictability of implants that achieve osseointegration. A number of articles also demonstrate potential complications and confirm that clinical success of any endosseous implant is highly dependent on the surgical skill of the dentist and his case selection, which cannot be controlled by the implant manufactures. Considering the high benefits and low risks of endosseous implants, as well as the usually detailed informed consent that most patients are required to sign, the entire PMA exercise, according to DIMA’s position, is not in the public’s interest. The anti competitive effect will result in higher costs to the profession and the public, as well as potentially compromise clinical success due to the reduced number of implant and prosthetic options. The need for different studies for each location and application only serves to make the costs prohibitive. Considering that the FDA guidelines do not even indicate a minimal success rate that must be demonstrated in any of the studies in order for the product to be sold, current FDA regulations appear adequate to assure safety.
Nobelpharma sent the FDA a letter, dated February 2, 1990, along with several articles by Dr. Thomas Albrektsson, a paid consultant for Nobelpharma. These articles, according to Nobelpharma’s letter, support the Swedish Trade Council’s position that "Implants can not be treated as a generic." It appears from Nobelpharma’s February 2, 1990 letter to the FDA that they know what is going to be in Albrektsson’s articles before they are even finished:
Reference supporting our comment No. 5, Albrektsson/Sennerby, 1990 is not attached to this letter. It will be submitted as soon as finished. Albrektsson/Sennerby reference is very essential in the generic discussion and the differences between implant systems in the clinical outcome of implant therapy.
Several of Albrektsson’s articles, submitted by Nobelpharma to the FDA, conveniently omit or misrepresent studies of competitive implant systems, thus potentially giving a false picture to the FDA. For example, an article by Malmqvist and Sennerby, critical of the Core-Vent System (JOMI 1990, Vol. 5, No. 1) is referenced in the articles by Albrektsson and Lekholm and Albrektsson and Sennerby. Albrektsson, Sennerby and Lekholm are or have been employees of the Brånemark Clinic in Gothenburg, or are paid consultants of Nobelpharma. The Malmqvist and Sennerby article reports on only 43 Core-Vent implants (47 placed, 43 followed). By applying a criteria of success related to measurement of crestal bone loss that was never used to determine success rates from any of the published Brånemark studies, the article reduced the Core-Vent success rate in the mandible from 88% (based on number of stable implants in function) to an artificially low 16%. The success criteria used in establishing success rates with Brånemark fixtures, according to Adell (JPD, 1983, Vol. 50, No. 2, Page 252) and Brånemark, Zarb, Albrektsson (1985 Textbook, Page 181), was "fixture survival rate" of implants that remain "clinically stable," which they equate to being "osseointegrated." To justify the Malmqvist and Sennerby anecdotal report, in light of the published results of the Patrick, Lubar, Buchs & Zosky Core-Vent Study of 1,605 implants with 96.6% overall success rate (Journal of Oral Implantology, 1989, Vol. XV, No. 2), the authors attempt to negate its validity by falsely stating that the criteria of success was not clearly stated. To the contrary, the Patrick, et al., study stated that it used osseointegration as its success criteria –– just as did the published studies on the Brånemark fixture. The Malmqvist and Sennerby article reported seven failures out of 10 Core Vent Implants placed in the partially edentulous maxilla. To put this into prospective, the Patrick, et al., study documented seven failures out of 342 Core-Vent Implants placed in the same applications. The most logical conclusion that can be drawn from this comparison is that Dr. Malmqvist failed to follow the Core-Vent surgical protocol, selected too large a diameter Core-Vent for the available bone width, or overloaded the implants by poor prosthetic design including connection to mobile teeth. The Core-Vent Implant’s ability to maintain osseointegration in function was amply demonstrated in the Patrick et al., study with 100% of the 51 free-standing maxillary single tooth replacements with up to a five year follow-up.
The FDA, faced with conflicting reports on implant success rates, will likely proceed with the call for PMAs. Core-Vent Corporation is supporting prospective, randomized, multi-center clinical studies using a research protocol developed at Harvard for our Core-Vent, Screw-Vent, Micro Vent and Bio-Vent Implants. Since the NIH Implant Consensus Statement (1988) attributed no more credibility to the Brånemark clinical studies than to studies presented on other systems, calling them all retrospective "case series studies," Nobelpharma’s claim (Nobelpharma Newsletter 1989, Vol. 3, No. 1), that theirs is "the only system which already measures up to the FDA’s proposed requirements" may be viewed in the same light as their previous misleading claims in brochures (1988) that they were "the only system to use osseointegration," or that they had achieved "99% long-term and complication-free success for bridges anchored in the lower jaw." Furthermore, Mr. Leif Ek, President of the Swedish Nobelpharma parent company, stated in Nobelpharma News (Vol. 3, No. 4, 1990) in reference to FDA’s proposed requirements that "the Brånemark System may exceed them!" The interviewer went on to ask Mr. Ek, "Isn’t that why you want to see them brought into force, then?," to which Mr. Ek candidly answered, "I won’t deny that we are businessmen." Nobelpharma would certainly benefit from FDA regulations that could result in substantial price increases of their competitor’s products or elimination of competitors altogether. Core-Vent believes that the current level of FDA regulations and market competition has served the public well.