Tebbetts says he now has more than opinion on his side. In three separate studies he has recently published in the Journal of Plastic and Reconstructive Surgery, Tebbetts followed 1,662 patients for up to seven years who had used the McGhan Style 468 and found there were extremely low complication and shell failure rates--far fewer than comparable studies published by manufacturers on round implants. "The difference is huge," he says.
But Hamas finds Tebbetts' science wanting--too many unaccounted for variables and questionable research that only examines a McGhan product in which Tebbetts has a financial stake. Besides, he believes the research is a distraction from the real issues of misrepresentation and false advertising. The problem remains Tebbetts' book, he says, whose opinions and illustrations about naturalness amount to little more than promotional pandering for the anatomic:
"Do you want a result that looks more natural than excessively round and bulging in the upper breast?" asks the book rhetorically. "Do you want an adequately filled implant with minimal risk of shell folding and risk of shell rupture?" It then tells those who have answered these and three other questions affirmatively: "You'll almost certainly want an anatomic implant," which the book later claims is "ideal for the majority of first-time augmentation patients." Because he requires each of his patients to read the book, it's not surprising that Tebbetts has performed more "augmentations with anatomic breast implants that any other surgeon worldwide," according to Tebbetts' own Web site.
One Dallas plastic surgeon (Hamas denies it was him) filed a complaint against the book with the ethics committee of the American Society of Plastic Surgeons, claiming in essence that The Best Breast made it impossible for women to discriminate between medical fact and opinion. That complaint, however, was resolved in Tebbetts' favor. "Does everyone agree with what's in the book? Obviously not," Tebbetts says. "But it's been reviewed by the ethics committee for the society. It's our opinion; it's our best opinion based on what we know right now."
As their controversy gained momentum, it was hard to tell where science stopped and ego started. In January 2001, Hamas shared the same podium with Tebbetts before about 250 plastic surgeons at a symposium in Atlanta. During his speech, Hamas, who is generally quiet and unassuming, not only took issue with many of the illustrations and "opinions" in The Best Breast, he was downright provocative about it: "Could [the illustrations] deceive or mislead a woman about round implants? Would they make her choose an anatomic implant? McGhan was forced to do the right thing. They withdrew the anatomical implants ads and claims...Now what about The Best Breast?" he asked. Should the book be corrected? Withdrawn? Hamas challenged Tebbetts to do the "right thing."
And Tebbetts challenged Hamas to a fight. "He said this is not the forum for personal assaults," one doctor recalls. "So, we should go out behind the woodshed and just settle it there."
Cooler heads prevailed. Sort of.
On May 22, Tebbetts filed a complaint with the FDA, questioning the ethics and protocol of Hamas' original X-ray study and suggesting it might have violated federal mammography regulations. Tebbetts had raised similar allegations--lack of informed consent procedures, lack of anyone authorizing the study, the lack of a qualified radiologist--in his previous comments to the medical journal. The FDA found no federal violations and forwarded the complaint to the Texas Department of Health, which conducted its own investigation and also issued no violations. During Hamas' interview with the health inspector, he contended that the real motivation behind the Tebbetts complaint was the attacks he had leveled against The Best Breast for being scientifically insupportable. On December 6, the health department forwarded a copy of its investigation to the Texas State Board of Medical Examiners "for possible action" regarding the "unethical behavior of the complaining physician [Tebbetts] with reference to the advertising claims" related to "breast implants used by that physician."
Even if the Texas medical board refuses to examine the ethical dilemma posed by anatomic and round implants, that won't settle the issue. It's more likely to be resolved in California, where a class-action lawsuit alleging that McGhan deceived Angie Jameson and thousands of similarly implanted women is working its way through state court. Dallas attorney Marc Stanley represents the plaintiffs, both current and prospective. "Our issue is a simple one," he says. "The company sold 100,000 to 200,000 sets of its shaped implants based on the false representation that they were more natural, more anatomically correct, and women paid up to $500 more a set. That's deceptive business practice, and they should give the money back."
Not surprisingly, McGhan has no intention of doing so, raising 25 defenses to the lawsuit and alleging, among other things, that the plaintiff-patients relied on the "learned" judgment of their doctors to make medical decisions--not some national ad campaign. "We think the lawsuit is entirely without merit, and we intend to defend ourselves vigorously," says attorney David Bamberger, general counsel for the Inamed Corp. (McGhan is a division of Inamed). "There are hundreds of surgeons who continue to use shaped implants and get excellent results."