Women weren't the campaign's only targets. Plastic surgeons were invited to participate in McGhan's "Aesthetic Marketing Alliance" and become one of its "preferred surgeons." To attain this status, a doctor was obliged to pay an ongoing fee and implant "eight pair of Style 468" anatomicals. In exchange, the doctor would receive referrals and advertising support generated by McGhan's national ad campaign and Web site. In 1998, more than 1,000 physicians joined the Aesthetic Marketing Alliance, and the campaign generated more than 100,000 plastic surgeon inquiries by prospective patients. It was in every way a success, both for McGhan and Tebbetts, who acknowledges he had a "financial arrangement" with McGhan dating to 1993.
Many plastic surgeons had strong ethical reservations about the marketing alliance. "If it wasn't unethical, it was close to it," says veteran Dallas plastic surgeon Harlan Pollock, a regional spokesman for the ASPS. "Physicians must use their best medical judgment when advising a patient. A financial relationship with a manufacturer that requires you to use its implants might cloud that judgment." Doug Free, the general counsel for the California Society of Plastic Surgeons, expressed similar reservations. "Any form of consideration in exchange for patient referrals is unethical and illegal under California law." The ASPS voiced its own objections, and McGhan modified the program somewhat. But it ultimately died its own death, says one McGhan official, because it was too expensive for surgeons. And most preferred to use round implants, anyway, believing they did a comparable job at a lower price.
In May 2000, the FDA approved the safety of saline implants over the objections of women's advocacy groups that contended the agency reached the wrong result, failing to take fully into account their high complication rates. (More than 40 percent of patients receiving saline-filled implants had at least one complication within the first three years after surgery.) As part of the same approval process, the FDA prohibited implant manufacturers from marketing their shaped implants as "more anatomical," natural or having "better anatomical results."
"The burden of proof falls on the person who wants to make a positive statement that his product is better than another," explains Dr. Boyd Burkhardt, who served as a member of the FDA advisory panel that recommended the ban. "McGhan and Tebbetts had no proof. They couldn't pull it out of thin air."
The FDA had no objections, however, if manufacturers sought to promote their implants as "shaped" or "contoured." The labeling ban dealt another blow to the Style 468 anatomical, though it wouldn't be the last.
When Angie Jameson went to Dr. Tebbetts, she didn't know the difference between an anatomic implant and a round one. "I just didn't want my breasts entering the room before I did," she says. Tebbetts told her he had invented the anatomic, claimed it was state of the art. "He said when you stand up, it falls like a natural breast, " she recalls. "When you stand up with the round, it doesn't teardrop. It stays round."
Tebbetts says he did not recommend any specific type of implant. "Like all our patients, she was offered a choice of any type of implant she desired, by any manufacturer she desired." She was also given information about shell folding issues, he says, "and she personally selected the implant she received."
Not surprisingly, she chose the anatomic, wanting it placed over the muscle rather than under (quicker recovery), wanting it textured rather than smooth (less chance of implant movement). Things went so well with her surgery, Tebbetts asked her to speak with a reticent patient and allay her concerns. She would later be glad she refused.
For the next three weeks, she felt fine, believing what she had been told, that she had a more natural look. Then one morning while in bed, she reached for a glass of water, heard a pop inside her chest and felt a sharp, shooting pain. She phoned Tebbetts' office and learned he was out of town. His staff thought she was hemorrhaging--a risk that had nothing to do with the shape of the implant and one that Tebbetts now says "was an exceedingly unusual occurrence" that might have been caused by "something other than surgery." Immediately her chest swelled and she called an ambulance. At Baylor Hospital, another doctor on call for Tebbetts performed a second surgery and stopped the bleeding.