Breast Implants Undergo Reconstruction

http://cn.nytstyle.com/health/20151210/t10implants/zh-hant/

人造乳房正經歷變革

新知ABBY ELLIN2015年12月10日

Rex C. Curry for The New York Times

整形醫生羅伯特·S·黑馬斯博士發明了一種叫做「Ideal Implant」的東西，稱「不使用硅膠，但能擁有同樣的天然感受」。

希拉里·米勒(Hilary Miller)的乳房變樣了。在生了兩個孩子和許多次哺乳之後，它們不再像年輕時那麼漂亮。「我想讓它們看起來像過去那樣，」目前在達拉斯的一家美容公司工作的米勒說。

她一直想去隆胸，但對硅膠人造乳房存有疑慮。1992年，硅膠假體被禁止在市場上使用，並接受安全評估，在2006年又重獲美國食品與藥品管理局（Food and Drug Administration，簡稱FDA）認可。在多年的訴訟和專家小組的研究之後，硅膠被認為是安全的，但污點並沒有徹底消失。許多女性仍然害怕「隱性破裂」，即只有通過核磁共振成像(MRI)才能發現的裂口。MRI檢測需要花費數千美元，通常不在保險覆蓋的範圍內。許多女性還害怕異物滲入血管，引發自身免疫疾病或癌症。

「我不希望身體里有我不了解的東西，」現年38歲的米勒說。她也不想選擇生理鹽水假體，因為她不喜歡好像襯衫下面放着兩隻水球的感覺。

Rex C. Curry for The New York Times

今年9月，米勒聽說了一種叫做「Ideal Implant」的東西，自稱「不使用硅膠，但能擁有同樣的天然感受」。這種植入物的發明者是達拉斯整形醫生羅伯特·S·黑馬斯(Robert S. Hamas)博士，由生理鹽水製成。但它不會像生理鹽水假體那樣四處晃動，或是出現摺疊或褶皺，卻能夠像硅膠一樣柔軟。

「它們很好看，感覺也很自然，」米勒說。她花了7000美元，做了這種假體植入和乳房提升手術。「我喜歡它們在衣服里服服帖帖的感覺。我很滿意。」

《整形外科檔案》(Archives of Plastic Surgery)於2004年刊登的一份分析報告發現，在隆胸手術八年後， 9%到12%的患者的硅膠假體會出現隱性破裂。FDA建議植入硅膠假體的女性在手術三年後做一次MRI檢查，此後每兩年做一次。與硅膠不同，生理鹽水假體如果泄漏，尺寸會縮小，很容易看出來。

自1992年硅膠植入物被 暫停後不久，黑馬斯博士就一直在研究他的這款產品。他想找出一種辦法，讓生理鹽水的人工乳房不再像威士忌酸酒那樣四處晃蕩。在反覆試驗之後，他製作了一系列的植入物外殼，把它們套在了一起，就像俄羅斯套娃一樣，並用兩個單獨的空間來盛放生理鹽水。這種內部結構限制了生理鹽水的流動，同時還能支撐假體的邊緣，減少褶皺的出現。

黑馬斯博士於2006年創辦了這家名為Ideal Implant的公司，它由120名董事會認證或合乎資質的整形醫生控股，2014年經FDA審核通過。這種假體今年9月開始提供給公眾，不過這麼說有些勉強。

除了手術費，一對Ideal Implant人造乳房的價格是1500美元，略高於硅膠假體，目前只有股東和為FDA從事調查的45名醫生（與這家公司都沒有財務關係）能夠獲得這款產品。需求遠遠超出了供應，因此醫生們手頭都積攢了一個等待這種假體的女性名單。

「10年前，當黑馬斯醫生向我展示這款產品時，我覺得在生理鹽水的基礎上進行改進是個好主意，尤其是因為那時候我們別無選擇，」亞拉巴馬州伯明翰的整形醫生詹姆斯·C·格勒廷(James. C. Grotting)博士說。「我沒想到會需要這麼長時間。」

加州比弗利山的整形醫生凱文·布倫納(Kevin Brenner)博士是FDA最初的調查員之一，他說，他的一些患者已經等了五年。「隆胸是非常個人化的決定，她們必須能夠接受放置在她們身體里的東西，」他說。「生理鹽水和硅膠都各有利弊。Ideal Implant在兩種範疇中都是最佳選擇。」

Rex C. Curry for The New York Times

人造乳房的結構示意圖

並非每位醫生都支持這種產品。美國整形外科學會(American Society of Plastic Surgeons)上一任主席、紐約整形醫生斯科特·格萊斯伯格(Scot Glasberg)博士表示，他接到過五六個醫生打來的電話，都表達了對Ideal Implant推向市場的擔憂。「它在間接告訴公眾，硅膠是不安全的，」他說。「我們已經花了大量時間來確保硅膠產品的安全性。我們不希望有任何人以哪怕是最不可能的方式來證明它們是不安全的。」

加州整形外科學會主席、聖莫尼卡的整形醫生史蒂芬·泰特爾鮑姆(Steven Teitelbaum)甚至認為不需要再發明一種生理鹽水假體。根據美國美容整形外科學會(American Society for Aesthetic Plastic Surgery)，2014年，只有20%的隆胸手術使用了生理鹽水。「沒人要求使用生理鹽水假體，除了實在想貪便宜的，或者希望擁有巨大的人造乳房但又想讓切口很小的女性，」泰特爾鮑姆說。（生理鹽水可以被注入到乳頭周圍，或者通過腋下的切口注入，然後慢慢脹大。）生理鹽水假體的感覺永遠不可能和硅膠一樣。

他擔心的還有數據，或者說數據的缺乏。FDA的許可根據的是發表於2012年9月號的《美容外科雜誌》(Aesthetic Surgery Journal)上的一項長達兩年的研究的初步結果。黑馬斯是這篇文章的作者之一。這家公司正在對近500名18至67歲女性進行一項長達10年的研究，該研究將於2019年完成。

最後，泰特爾鮑姆還苦惱於這種假體供應量有限。「如果你沒準備好推出產品，就不要發佈，」他說。「這是一種虛假發布。」

黑馬斯博士強調，他的公司很小，無法大量生產這種假體。如果沒有其他醫生的投資就不可能取得進展。他認為女性們也擔心這一點。

「許多整形醫生說， 『不用擔心硅膠的不良反應，它已經通過了FDA的審核，』 」他說。「FDA已經宣布，硅膠是安全的，但是女性應該終生每兩年做一次MRI檢查，看看是否出現破裂，因為光是體檢或是肉眼觀察是看不出來的。」

格勒廷醫生和其他投資者說，他們不會因為Ideal而發大財。他們很願意向患者披露他們的相關經濟利益。「我向一些女性展示目前可以獲得的所有設備，解釋每種的優缺點，」他說。（醫生向患者披露自己與某款產品的經濟利益，是各州的醫療委員會的要求）

新澤西霍博肯29歲的平面設計師蒂娜·考夫曼(Dina Kaufman)，就在紐約整形醫生、投資人謝雷爾 ·阿斯頓 (Sherrell Aston)那裡等待做這個手術。過去六年，考夫曼女士體重輕了100磅，她想做乳房提升和隆胸，恢復減肥之前的胸型。

「生理鹽水的假體看起來不那麼自然，一看就是假的，至於硅膠，我聽說了太多可怕的故事，」她說。「我還太年輕，我不想要為它們煩惱。」

幾年前她讀到了一篇關於Ideal Implant的文章。雖然她的醫生是這款產品的小型投資人，她對此完全不介意。「我反倒更想做這個手術了，」她說。

翻譯：王湛

Breast Implants Undergo Reconstruction

By ABBY ELLINDecember 10, 2015

Hilary Miller’s breasts are not what they once were. Two children and many feedings later, they simply don’t have the perkiness of youth. “I’d like them to look the way they used to,” said Ms. Miller, who works at a beauty company in Dallas.

She has long wanted an augmentation, but she worried about silicone implants. Never mind that the Food and Drug Administration approved them in 2006, after they wereremoved from the market in 1992 while the F.D.A. evaluated their safety. After years of litigation and expert panel study, silicone gels were deemed safe, but the stigma has remained. Many women still fear “silent ruptures,” that is, tears that are undetectable without an M.R.I., which can cost thousands of dollars and usually isn’t covered by insurance. Many women also fear foreign substances coursing through their veins, worrying that they cause autoimmune diseases or cancer.

“I don’t like the idea of something in my body that I don’t know about,” Ms. Miller, 38, said. Saline didn’t appeal to her; she didn’t want to feel as if two water balloons were dwelling beneath her blouse.

Rex C. Curry for The New York Times

Dr. Robert Hamas holding a new saline breast implant that he developed.

So in September, Ms. Miller got something called the Ideal Implant, which bills itself as “natural feel without silicone gel.” The implants, created by a Dallas plastic surgeon, Dr. Robert S. Hamas (pronounced HEY-mus), are made of saline. But instead of bouncing around and potentially scalloping or folding, as saline implants tend to, they are as soft as gel.

“They look good; they feel natural,” said Ms. Miller, who paid about $7,000 for the implants and a breast lift. “I like the way they fit in my clothes. I’m very happy.”

A 2014 analysis in the Archives of Plastic Surgery found that silent ruptures occurred in 9 to 12 percent of cases eight years after implantation. The F.D.A. advises women with silicone-gel implants to get an M.R.I. three years after the original surgery, and then every other year thereafter. Unlike silicone, saline implants deflate if there’s a leak, so it’s easy to tell if there’s a problem.

Dr. Hamas has been working on his product since 1992, shortly after the moratorium on silicone. The idea was to figure out a way to keep the saline from sloshing around like a whiskey sour. After much trial and error, he created a series of implant shells nested together, like Russian dolls, and two separate chambers that hold saline. This internal structure limited the saline’s ability to move, while supporting the implant edges to reduce wrinkling.

The company, Ideal Implant Inc., which he started in 2006, is majority owned by about 120 board-certified or board-eligible plastic surgeons, and gained F.D.A. approval in 2014. It was made available to the public in September of this year. Sort of.

The Ideal Implant, which costs $1,500 a pair in addition to surgical costs, slightly higher than silicone implants, is only available to the shareholders and 45 doctors who investigated them for the F.D.A. (none of whom have a financial stake in the company). But demand far outweighs supply, so doctors have been compiling waiting lists of women who want them.

“Ten years ago, when Dr. Hamas showed it to me, I thought it was a good idea to improve upon saline implants, especially back then when that was all we had,” said Dr. James. C. Grotting, a plastic surgeon in Birmingham, Ala. “I didn’t know it was going to take so long.”

Dr. Kevin Brenner, a plastic surgeon in Beverly Hills, Calif., who was one of the original F.D.A. investigators, said he has patients who have been waiting five years. “Breast augmentation is a very personal decision for most women, and they’ve got to be comfortable with what I’m putting in them,” he said. “Both saline and silicone have upsides and downsides. The Ideal Implant is the best of both worlds.”

Rex C. Curry for The New York Times

A diagram showing how the implant has been built with baffles.

Not every doctor is on board. Dr. Scot Glasberg, a plastic surgeon in New York and the immediate past president of the American Society of Plastic Surgeons, said he has received calls from a half-dozen doctors concerned about the marketing of the Ideal Implant. “It suggests in a roundabout way that silicone is not safe,” he said. “We’ve spent such a large amount of time ensuring the safety of silicone products. We’d hate to have a situation where anyone, even in a remote way, is trying to lay a foundation that they’re not safe.”

Dr. Steven Teitelbaum, a plastic surgeon in Santa Monica and president of the California Society of Plastic Surgeons, doesn’t even see the need for another saline implant. According to the American Society for Aesthetic Plastic Surgery, in 2014, 20 percent of breast augmentations involved saline. “Nobody comes in asking for saline except real bargain hunters or women who want really enormous implants but small incisions,” Dr. Teitelbaum said. (Saline implants can be inserted around the nipple or through a cut in the underarm, and then inflated.) “A saline implant can never feel like a silicone implant.”

He also worries about the data, or lack thereof. F.D.A. approval was based on the initial results of a two-year study, published in the September 2012 issue of the Aesthetic Surgery Journal. Dr. Hamas is one of the authors. A 10-year study of nearly 500 women ages 18 to 67, also conducted by the company, is underway. It will conclude in 2019.

And finally, Dr. Teitelbaum is bothered by the implant’s limited availability. “You don’t launch a product when you don’t have it ready to ship,” he said. “It’s a false launch.”

Dr. Hamas stresses that his company is tiny, which accounts for its inability to produce mass quantities of the implant. It wouldn’t have been able to get off the ground without investments from other doctors. And he believes women are worried.

“A lot of plastic surgeons say, ‘Don’t worry about silicone, the F.D.A. has approved it,’” he said. “The F.D.A. has said silicone gel is safe but women should get an M.R.I. scan every other year, for life, to see if they’re ruptured because you can’t tell by examining a patient or looking at it.”

Dr. Grotting and other investors say they aren’t going to get rich from the Ideal. They are happy to disclose their financial interest to patients. “I show women all the devices available, and explain the pros and cons of each,” he said. (Informing patients of financial interest in a product is determined on a state-by-state basis by state medical boards.)

Dina Kaufman, a 29-year-old graphic designer in Hoboken, N.J., is on the waiting list with Dr. Sherrell Aston, a plastic surgeon in New York and an investor. Over the last six years, Ms. Kaufman has lost about 100 pounds, and wants a breast lift and implants to help bring back the shape of her breasts from before she lost the weight.

“The saline wasn’t as natural and you could tell they were fake, and with silicone I read a lot of horror stories,” she said. “Because I’m so young, I didn’t want to have to worry about them.”

She read an article about the Ideal Implants a few years ago. That her doctor is a minor investor in the company doesn’t bother her at all. “It makes me want it even more,” she said.