Eventuality of saline lawsuits?

[Guest guest]

I found this article very interesting..... Here are some snippets from it. Bold highlights are my doing. But do I think the FDA will ever ban saline implants? Ha. In my dreams.

http://pegasus.rutgers.edu/~record/articles/vol25/25rlr1/implants2.html

11) Today, only two manufacturers of breast implants survived the 1992 silicone gel breast implant moratorium and continue to manufacture saline breast implants; Mentor H-S and McGhan Medical.(31) They are most at risk if the FDA changes its position on saline breast implants.

(12) United States courts have largely supported verdicts in cases where evidence is given that silicone gel breast implants cause health problems in the women who have them. Although the formal medical and epidemiological(32) data supporting such awards is inconclusive at best, juries are no doubt influenced by the fact that silicone, a substance foreign to the body, is implanted. While silicone is not known to cause any human health complications,(33)silicon, in appreciable amounts does.(34) It is not the chemical composition or toxicity of silicone and silicon, rather it is the microparticles of silicon that the implant sheds, in the form of silicone gel, which cause any systemic responses.(35) Silicon does exist in silicone, both in the silicone in silicone gel breast implants and in the shells that surround both silicone gel breast implants and saline breast implants. Silicone contains silicon, oxygen and other organic elements that are chained and cross-linked together at the molecular level.(36) The length of these chains, and the complexity of the cross-linking determines how hard or soft the silicone will be.(37) By varying the combinations of the elements present, and by using heated or vacuum conditions, the molecular weight of the silicone changes, and the silicone can range in viscosity from a hard resin, to the more fluid like gel(38) in silicone gel breast implants. Although silicone-gel, has been labeled the "bad boy" in most treatments of the subject, the identical components are present in all silicones, including the silicone envelope of saline filled breast implants.

(18) Although the FDA has endorsed saline breast implants as safe, the agency also acknowledges certain risks that are associated with the devices.(55) Local risks acknowledged by the FDA include: capsular contracture (a painful build up of scar tissue that hardens and deforms the implant and breast); calcium deposits around the implants requiring extraction; follow up surgery to correct implants that deflate or reposition; post surgical infection; hematomas or bruising requiring draining of the damaged tissue; poor healing of the insertion wound; and change in sensation around the breast and nipple.(56) Systemic risks, identified as possible but unknown are:(57) autoimmune disease; effects on breast fed children;(58) and enhanced risk of cancer.(59) The FDA also acknowledges that bacterial or viral infection of the saline solution may occur. This conclusion seems to have been born out of studies concluding that a variety of microbes may grow inside saline breast implants that were improperly cared for before their implantation. Whether the proliferation of viruses and bacteria in saline solution poses a threat to the health of implantees is unknown.(60) However it is clear that saline breast implants can become engorged with other bodily fluids, including water, glucose and protein, that permeate through the silicone shell.(61) The addition of these fluids causes marked enlargement of the implant and discoloration of the saline, visible through the shell. Researchers described the former saline solution as a "brownish yellow material that had the consistency of serum."(62) Certainly knowledge that bacteria, viruses and other "germs" were living in that liquid, inside a saline breast implantee's body could cause an adverse emotional reaction. Indeed, researchers noted that reports of such occurrences, "have caused considerable alarm and fear to saline implant recipients."(63) (19) More troublesome than offensive liquids and colonies of microbes inside saline breast implants is the possibility that some saline breast implants, more so than silicone gel breast implants, may put silicone into the body. Capsular contracture, or fibrous scar tissue around the implant, is a common condition caused in part by the unnaturally smooth surface of the breast implant.(64) To combat the effects of capsular contracture, many women were implanted with saline breast implants with a textured or rough surface.(65) Silicone shells do shed fragments of silicone into the body. Unfortunately, textured shells, as opposed to smooth shells, are more likely to shed silicone into the body.(66) Some believe that these particles of silicone (as opposed to the subtle chemical difference between silicone gel and the firmer silicone of the envelope) cause the systemic problems associated with silicone gel breast implants.(67) While silicone gel breast implants have long been known to weep or bleed the gel through the shell into the system(68), saline was thought to be safe. (20) The sensational nature of the "infected" saline breast implants and textured saline shells that shed fragments of silicone into the system certainly pose a threat to the reputation of saline breast implants. Still, there is no proof that these complications or any of the risks that the FDA has identified, pose any systemic threat to women with saline breast implants. Claims of this nature make up most of the complaints about silicone gel breast implants and are the focus of the mass litigation. Regardless, if plaintiffs learn of these complications, fears may arise, and so may suits against McGhan and Mentor. However, what could possibly happen to bring this obscure medical information to the forefront of the public's consciousness?

(31) Here is how saline breast implant plaintiffs can establish their roots to legal precedents established in earlier silicone gel breast implants cases; it's the silicone in the envelope, not the gel inside, that causes problems. Therefore it is irrelevant that the envelopes are filled with saline. (32) Only a handful of reported decisions exist that mention saline breast implants. Their doctors told these plaintiffs that they were receiving saline breast implants. Instead, when they learned they had received silicone gel breast implants, they sued.(92) The significant is that at least one of these plaintiffs sued for the express reason that she became aware of problems associated with silicone gel breast implants through the media's coverage; "Bess became aware of media coverage regarding the dangers of silicone gel implants. She then went to the hospital to review her records, and discovered for the first time that her implants consisted primarily of silicone gel."(93) This case accurately depicts how susceptible persons are to stories presented by the media.(94) Presumably, these plaintiffs did not feel that earlier class action suits were applicable to them because they believed they were implanted with saline breast implants, not silicone gel breast implants. It is unknown how commonly held these beliefs are. (33) Assuming that saline breast implant plaintiffs choose to decide their health complications are caused by their implants, manufacturers McGhan and Mentor may have a fresh fight on their hands. Numerous factors have been identified as contributing to mass tort lawsuits, such as the silicone gel breast implants.(95) With respect to saline breast implants, all are present and suggest that regardless of whether or not the FDA decides to ban the device, the possibility that saline breast implants plaintiffs could litigate extensively is real.

(36) Finally, plaintiffs' lawyers specializing in breast implant litigation are a contributing factor to the potential for overwhelming litigation respecting saline breast implants.(103) Lawyers are especially well organized, and prepared to take up litigating saline breast implant cases. Combined with an entire newsletter devoted to litigating breast implant cases, called Medical/Legal Aspects of Breast Implants, legal newspapers and journals regularly run "how to" articles on tapping into the huge and (potentially) hugely profitable realm of litigating breast implant cases against manufacturers.(104) Moreover, lawyers are not shy about advertising that breast implant cases are their specialty and that women who have them should consider litigation over their complaints.(105) Attorneys aggressively advertise their breast implant litigation expertise in newspapers and on billboards and television, and at least one law firm has set up a toll free hotline to encourage women contemplating litigation to call their office.(106) Even the Association of Trial Lawyers of America has a implant litigation group, whose co-chair declares, "I will sue people so that I can protect women."(107) (37) The stage appears to be set: if the F.D.A. ever concludes that saline breast implants are unfit for public use, it will ban them. The media will pick up the story and sensationalize it to make a profit. Women with saline implants will become frightened. Despite earlier settlements naming saline implanted women as class members, many saline implanted women who opted out of those classes or weren't notified of the action will file suit, and will have no trouble finding experienced attorney to represent them. Given the current state of the admissibility of scientific evidence at trial, juries will be able to reasonably conclude plaintiff's injuries were caused by saline implants. The settlements will be staggering. (38) The manufacturers' only affirmative defense is that silicone gel was the original culprit, not the silicone shell, and that saline implants do not have this compound present.(108) Aside from other procedural defenses such as prophylactic legislation and statute of limitations,(109) manufacturers' defenses are few. The nation's judicial system must prepare to deal with this seeming eventuality.